Remote tissue retraction device

ABSTRACT

A medical device for managing tissue in an organ, such as the stomach, for retracting or positioning tissue and related organs to allow certain regions of the stomach to be acquired for a gastroplasty procedure. The medical device includes an elongated body having a proximal end and a distal end, and a tissue treatment device attached to the distal end of the elongated body. The tissue treatment device includes a first jaw opposite a second jaw, and each jaw is adapted to acquire tissue. A retractor is disposed along the tissue treatment device and adapted to be moveable from a delivery position to a retraction position to move or manage the tissue of the stomach. The medical device also includes a collapsible barrier disposed between the first and second jaws of the tissue treatment device to direct tissue into the first and second jaws separately.

CROSS REFERENCES TO OTHER APPLICATIONS

This application is a continuation of application Ser. No. 11/282,320filed Nov. 17, 2005 which is a continuation-in-part of application Ser.No. 10/991,140 filed Nov. 17, 2004, the entire contents of which areincorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical apparatuses andmethods for remotely retracting or positioning tissue. Moreparticularly, the present invention relates to tools and methods fortransoral tissue manipulating and managing within the stomach fortreatment of the gastrointestinal tract, including, treatment of GERD,varices, and obesity.

2. General Background and State of the Art

At present, there are several surgical procedures for treating obesity,gastroesophageal reflux disease (“GERD”), varices, cancer, hormonalexclusion and the like. To treat these ailments, there are certainprocedures that use devices for tissue acquisition and fixation, orgastroplasty, that create a partition within a hollow body organ, suchas the stomach, esophageal region, antrum, pyloric region and otherportions of the gastrointestinal tract. Currently, there are proceduresthat advance devices in a minimally invasive manner within a patient'sbody, e.g., transorally, endoscopically, percutaneously, etc., to createone or several divisions or plications within the hollow body organ.Such divisions or plications can form restrictive barriers within theorgan, or can be placed to form a pouch, or gastric lumen, smaller thanthe remaining stomach volume to essentially act as the active stomachsuch as the pouch resulting from a surgical Roux-En-Y gastric bypassprocedure. Examples of placing and/or creating divisions or plicationsmay be seen in further detail in U.S. Pat. No. 6,558,400; U.S. patentapplication Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patentapplication Ser. No. 10/417,790 filed Apr. 16, 2003, each of which isincorporated herein by reference in its entirety.

During these gastroplasty procedures, unwanted or non-target tissue,described as “rogue” tissue (tissue that may non-intentionally take theplace of normally targeted tissue), for example excess fundus tissues orpleats or folds in the targeted tissue, can become involved with thetissue treatment device that performs a therapy to the stomach tissue.It can be problematic to have non-target tissue being acquired by thetissue treatment device for any number of reasons since the resultinggeometry of the altered stomach can be critical to clinical success ofthe therapeutic procedure. For example, in the case of gastroplasty forpurposes of creating a small pouch to mimic the pouch created by thesurgical procedure (Roux En y gastric bypass), it may be critical tominimize the possibility of leaving unwanted stomas or openings in theresulting pouch geometry. If the pouch created is not within theclinically preferred range, it may not produce the desired restrictionnecessary for clinical efficacy. Pleats, folds or non-targeted tissuecan disrupt the desired geometry leading to a break down in the pouchitself (dehiscence of fastened region) or undesired clinical results.Control and positioning of the gastric tissue can be difficult due tothe stomach's mobility, thickness of the targeted tissue, the abundanceand slimy (slippery) texture of the gastric mucosa and the presence ofrugae (naturally occurring folds) along the interior of the organ.

Therefore, what has been needed is a device and method for retractingand/or positioning the stomach volume and related organs, to allowcertain regions of the stomach to be approximated from within thestomach volume for treatment of various disorders such as obesity, GERD,varices, cancer, hormonal exclusion and the like.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for transorallyretracting or positioning the stomach tissue and related organs to allowcertain regions of the stomach to be acquired and treated by a tissueacquisition and/or gastroplasty device. For purposes of thisspecification the term “retraction” or “retracting” refers to direct orindirect movement of tissue either away from or towards a therapeuticelement. In some cases, the terms are used to describe holding orblocking tissue where it lays, and providing no appreciable movement ofthe tissue at all. The term “tissue” may encompass organs, a series oftissue layers, a single tissue layer, regions of tissue, or combinationsof all of the above.

The present invention includes a device for managing tissue in an organ,such as the stomach. The device includes a retraction section that canbe actuated or deployed, or naturally designed to perform within thestomach to retract, manipulate, or block non-target tissue away from atarget region, a region of tissue that is targeted for a medicalprocedure. In one aspect, the device can be used separately along with atissue treatment device (device used to perform a therapy to the targetregion) or the device can be integrated or coupled with the tissuetreatment device. Integrating the retraction device with the tissuetreatment device means that the two devices are combined into onedevice. If desired, a gastroscope or endoscope can be used along withthe device to view targeted tissue and any surrounding tissue to assista physician in the procedure. Such an endoscope may also act as theretraction device of the present invention. It is also contemplated thatan endoscope or other optical system may be integrated into thetreatment device as disclosed. In other aspects of the presentinvention, more than one retraction device and/or methods may be used incombination with one another to retract or manipulate targeted ornon-target tissue. In one aspect, the present invention is performedminimally invasively. The procedure of the present invention may also beperformed with laparoscopic assistance, or a combination of transoraland laparoscopic techniques.

The present invention retractor device, either separate or integrated,can perform several functions. First, the retractor device pulls away,blocks or otherwise manages rogue tissue, for example excess fundustissues or pleats or folds in the targeted tissue, from being involvedin the tissue treatment device. Also, the retraction device organizesthe targeted tissue by flattening or removing wrinkles and sub-foldsfrom the desired folds of the targeted area. The prospective tissue thatwill form the plication (or pouch or sleeve if the device is positionedin the organ to achieve that result) can then be suctioned into, graspedor brought to members of the tissue treatment device for therapy. Anyflattening of rugae is beneficial during the surgical procedure toachieve durable and precise fastening. Further, the retraction devicecan support the placing of the tissue treatment device within thestomach in the desired sleeve forming location. The retractor device canhelp move the tissue treatment device closer to the lesser curve of thestomach or target tissue surface, or the retractor device can be used toinitially move the stomach to bring the lesser curve of the stomach ortarget tissue surface, to the tissue treatment device. The retractordevice or feature can also apply axial tension along the lesser curve ofthe stomach or target tissue region, to achieve both the desiredplacement of the device and tissue retraction. Another advantage is thatthe retractor device can retract or accommodate inter-abdominal pressurefrom the weight of internal organs and the abdominal wall. The retractorshould be strong enough to lift and bear the weight of internal organsor it can orient the stomach in a direction that does not encounter suchloads. Yet another advantage is that by having a flexible formed elementdistal to the tissue treatment device, it helps the tissue treatmentdevice pass tortuosity more easily and reduce trauma to surroundingorgans such as the upper gastrointestinal tract.

In another aspect, a tissue treatment device having a first jaw oppositea second jaw, integrated with a retractor may also include a collapsiblebarrier disposed between the first and second pod of the tissuetreatment device. An advantage of the collapsible barrier, such as asail or a balloon, is that it can be raised or extended between the jawsof the tissue treatment device to help manage and control tissue, bydirecting the tissue into the separate jaws of the tissue treatmentdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an embodiment of a retractor device having a channelretractor section at a distal end.

FIG. 2 depicts a handle section of the retractor device shown in FIG. 1.

FIG. 3 depicts a perspective view of a U-shaped channel link element.

FIG. 4 depicts one embodiment of a channel retractor section having aroller disposed at a distal end.

FIG. 4A depicts the channel retractor section of FIG. 4 in a curvedretraction configuration.

FIG. 4B depicts a channel retractor section having a cone-shaped polymertip in a curved retraction configuration.

FIG. 5A depicts a cross-sectional view of one embodiment of a proximalchannel link element.

FIG. 5B depicts a cross-sectional view of one embodiment of a distalchannel link element.

FIG. 5C depicts one embodiment of a channel retractor section formedwith proximal and distal channel link elements in a straight insertionconfiguration.

FIG. 5D depicts the channel retractor section of FIG. 5C in a curvedretraction configuration.

FIG. 6 depicts an embodiment of a tissue treatment device positionedwithin a stomach cavity having channel link elements disposed proximalto the tissue treatment device.

FIG. 6A depicts the tissue treatment device of FIG. 6 with the channellink elements actuated to bend the tissue treatment device toward thelesser curve of the stomach.

FIG. 7 depicts a split-channel retractor in a straight deliveryposition.

FIG. 7A depicts a channel link element of the split-channel retractorshown in FIG. 7.

FIG. 8 depicts a perspective view the split-channel retractor in acurved retraction position.

FIG. 8A depicts a side elevational view of the split-channel retractorof FIG. 8.

FIG. 9 depicts one embodiment of a flat retractor in a deliveryposition.

FIG. 10 depicts the flat retractor of FIG. 9 in a curved retractionposition.

FIG. 11 depicts one embodiment of a tubular retractor in a straightdelivery position.

FIG. 12 depicts one embodiment of a bougie retractor attached to adistal end of a tissue treatment device in a straight delivery position.

FIG. 12A depicts an embodiment of a bougie retractor having a D-shapedbody.

FIG. 12B depicts the bougie retractor of FIG. 12 in a retractedposition.

FIG. 13 depicts an embodiment of a bowed retractor in a deliveryposition.

FIG. 14 depicts the bowed retractor of FIG. 13 with outer rods bowedoutwardly.

FIG. 15 depicts the retractor of FIGS. 13 and 14 with the outer rodsrotated in an arched shaped.

FIG. 16 depicts one embodiment of a loop retractor positioned within asleeve for insertion.

FIG. 17. depicts the loop retractor of FIG. 16 extended out of thesleeve into a retraction position.

FIG. 18 depicts another embodiment of a loop retractor having two loopsextending out of a sleeve in a retraction position.

FIG. 19 depicts one embodiment of a linear retractor integrated with atissue treatment device or a working element.

FIG. 20 depicts the linear retractor of FIG. 19 in a retractionposition.

FIG. 21 depicts one embodiment of an arm retractor integrated with atissue treatment device in a delivery position.

FIG. 22 depicts the arm retractor of FIG. 21 in a retraction position.

FIG. 23 depicts an embodiment of an articulating vacuum retractor in theretracted position within the stomach.

FIG. 24 depicts one embodiment of a vacuum-type retractor positionedalong the lesser curve of the stomach.

FIG. 25 depicts another embodiment of a vacuum-type retractor.

FIG. 26 depicts another embodiment of a vacuum-type retractor.

FIG. 27 depicts the vacuum-type retractor of FIG. 26 positioned near thegastroesophageal junction (“GEJ”) of the stomach.

FIG. 28 depicts an embodiment of a tissue tensioning retractorpositioned along a therapeutic device.

FIG. 29 depicts the tissue tensioning retractor of FIG. 28 with a secondpod translated distally relative to a first pod.

FIG. 30 depicts one embodiment of a wire retractor attached to a tissuetreatment device.

FIG. 31 depicts the wire retractor of FIG. 30 in a retractor position.

FIG. 32 depicts another embodiment of a wire retractor positioned alongthe greater curve of the stomach.

FIG. 33 depicts one embodiment of an endoscope retractor havingretraction hoops that form a sphere configuration when retracted.

FIG. 34 depicts one embodiment of a retractor device including a primaryretractor section and a secondary retractor section integrated with atissue treatment device.

FIG. 35 depicts one embodiment of a retractor device integrated with atissue treatment device and shown in use with an endoscope.

FIG. 36 depicts another embodiment of a retractor device integrated witha tissue treatment device, and a bore is shown disposed through theretractor section for the advancement of an endoscope.

FIG. 37 depicts an embodiment of a flat retractor integrated with atissue treatment device.

FIG. 38 depicts the backside of a flat retractor integrated with atissue treatment device showing a bore disposed through the proximal endof the flat retractor.

FIG. 39 depicts a bougie retractor integrated with a tissue treatmentdevice in a retracted position in use with an endoscope.

FIG. 40 depicts another embodiment of a bougie retractor having anindentation that is integrated with a tissue treatment device.

FIG. 40A depicts a cross-sectional view taken along line 40A-40A of FIG.40.

FIG. 41 depicts an endoscope in conjunction with a tissue treatmentdevice.

FIG. 41A depicts an endoscope in conjunction with a tissue treatmentdevice having a hinged septum.

FIG. 41B depicts a wire retractor integrated with a septum of a tissuetreatment device.

FIG. 41C depicts the integrated wire retractor of FIG. 41B with theseptum removed from the tissue treatment device.

FIGS. 42 through 42B depict an embodiment of a tissue treatment devicehaving a fan septum.

FIG. 42C depicts another embodiment of a tissue treatment device havinga multi-blade fan septum.

FIG. 43 depicts an embodiment of a flat band spreader shown in aretracted position.

FIG. 43A depicts a cross-section of the flat band spreader taken alongline 43A-43A of FIG. 43.

FIG. 44 depicts another embodiment of a retractor device integrated witha tissue treatment device, and this embodiment also incorporates agrasping forceps retractor.

FIG. 45 depicts a cross-sectional view of a stomach.

FIG. 46 depicts a cross-sectional view of the stomach taken along line46-46 of FIG. 45.

FIG. 47 depicts an embodiment of a form wire deployed within thestomach.

FIG. 48 depicts a cross-sectional view taken along line 48-48 of FIG.47.

FIG. 49 depicts an embodiment of a coil wire deployed within thestomach.

FIG. 50 depicts an embodiment of a kite retractor deployed within thestomach.

FIG. 51 depicts another embodiment of a kite retractor including asuctioning tube disposed within the stomach.

FIG. 52 depicts an embodiment of a balloon deployed within the stomach.

FIG. 53 depicts an embodiment of a bow retractor deployed within thestomach.

FIG. 54 depicts a distal end view of a tissue treatment device includinga septum having a hood that extends over the opening of the tissuetreatment device.

FIGS. 55A through 55D depict an embodiment of an axial retractorintegrated with a tissue treatment device.

FIG. 56 depicts a cross-sectional view of a stomach cavity that has beenreconfigured with a tissue treatment device.

FIG. 56A depicts a partial cross-section taken along line 56A-56A inFIG. 56.

FIG. 57 depicts one embodiment of a retractor device integrated with atissue treatment device positioned within the stomach and an endoscoperetroflexed in the stomach.

FIG. 58 depicts the integrated retractor device of FIG. 57 in theretracted position and a secondary wire retractor is also deployed.

FIGS. 59 through 63 depict one embodiment of advancing a tissuetreatment device to the stomach using a loop attached to the lessercurve of the stomach and a wire passed through the loop.

FIGS. 64 through 66 depict another embodiment of advancing a tissuetreatment device to the stomach using a balloon catheter.

FIGS. 67 through 72 depict yet another embodiment of advancing a tissuetreatment device to the stomach using a stiffening wire.

FIG. 73 depicts an embodiment of an extra-gastric retractor including alaparoscopic tube that attaches to the outer surface of the stomach.

FIG. 74 depicts a balloon catheter maneuvering the stomach by pressingagainst the outer surface of the stomach.

FIG. 75 depicts another embodiment of an extra-gastric retractorincluding a percutaneous endoscopic gastrostomy (“PEG”) tube.

FIG. 76 depicts another embodiment of an integrated tissue treatmentdevice in a delivery configuration with an endoscope alongside.

FIG. 77 depicts the tissue treatment device of FIG. 76 with jaws opened.

FIG. 78 depicts the tissue treatment device of FIG. 77 with the jawsopened and a retractor wire and sail in an extended configuration.

FIG. 79 depicts the tissue treatment device of FIG. 78 with the distaltip removed to better show a shroud which is connected to the backsideof the tissue treatment device to provide a passageway for theendoscope.

FIG. 80 depicts a backside perspective view of the tissue treatmentdevice of FIG. 79.

FIG. 81 depicts the tissue treatment device of FIG. 78 with theretractor wire and sail lowered before removal of a septum between thejaws of the tissue treatment device.

FIG. 82 depicts the tissue treatment device of FIG. 81 with septum andsail removed from the jaws of the tissue treatment device.

FIG. 83 depicts another embodiment of a tissue treatment device, whereinthe sail is attached to the retractor wire.

FIG. 84 depicts a perspective view of an embodiment of a tissuetreatment device with a balloon retractor attached to the septum of thetissue treatment device.

FIG. 85 depicts a side elevational view of the tissue treatment deviceand balloon retractor of FIG. 84.

FIG. 86 depicts a cross-sectional view taken along line 86-86 of FIG.85.

FIG. 87 depicts an alternative embodiment of a cross-sectional viewtaken along line 86-86 of FIG. 85.

FIG. 88 depicts another alternative embodiment of a cross-sectional viewtaken along line 86-86 of FIG. 85.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As will be discussed in detail below, retraction devices retract orstabilize tissue for transoral procedures, such as, stapling, ablationor cell necrosis, mucosal resection, biopsy, drug delivery, tattooing(marking for a later procedure), traumatic procedures such as scoring orabrading tissue to cause stricture, contraction, stimulating healing, orproviding hemostasis during procedures. More specifically, theembodiments of the invention are used for transoral tissue retractionalone, or in conjunction with other tools for treatment of the GI tract,including, treatment of GERD, varices, and obesity.

The retraction devices disclosed herein can be used in conjunction withother tools or can even be integrated with other tools forming onedevice or system of devices. Other tools that can be used with theretraction devices include gastroplasty devices for tissue acquisitionand fixation that can be used for creating a partition within a hollowbody organ, such as the stomach, esophageal junction, and/or otherportions of the gastrointestinal tract. The retraction devices disclosedretract or stabilize tissue so that the gastroplasty device can betterperform its function. Types of devices and methods that can be utilizedwith the preferred embodiments are found in U.S. Pat. No. 6,558,400,which issued May 6, 2003; U.S. Published Pat. App. No. 2004/0006351,which was published Jan. 8, 2004; U.S. patent application Ser. No.10/797,439, which was filed Mar. 9, 2004; U.S. patent application Ser.No. 10/797,303, which was filed Mar. 9, 2004; U.S. patent applicationSer. No. 10/686,326, which was filed Oct. 14, 2003; U.S. patentapplication Ser. No. 10/417,790, which was filed Apr. 16, 2003; and U.S.patent application Ser. No. 10/279,257, which was filed Oct. 23, 2002;the entirety of each of which are incorporated by reference herein.

Although it is preferred that the retraction devices of the preferredembodiments are advanced within a body transorally, a variety of othermethods may be used as well, including transanally, laparoscopically,endoscopically, percutaneously, etc. For ease of reference, thefollowing embodiments will be described as being advanced transorally tothe stomach, although the embodiments of the retraction device can beused within other body cavities as well. Throughout the specificationthe term “proximal” shall mean a point on a body that is nearest theoperator of the device, and “distal” shall mean a point on a body thatis furthest from the operator of the device.

Retraction Devices

In general, FIG. 1 shows a device 10 for managing tissue in an organthat includes an elongated body 12 having a proximal end 14, a distalend 16, and a working lumen 18 therebetween. A retractor section 20 isdisposed at or near the distal end and is adapted to be moveable from adelivery or insertion position to a retraction position for moving ormanaging the tissue of the stomach. In some embodiments, the device isconfigured for use with a second therapeutic device, such as anendoscope, a secondary retractor, or a tissue treatment device. Thereare several different embodiments of the retractor section, and eachwill be discussed below. As already discussed, the retractor section ofthe device functions to block, move, push, or pull away unwanted tissue(non-target tissue) from the desired tissue (target area) for transoralprocedures. In other words, the retraction or stabilization device isused to manipulate or stabilize targeted or non-target tissue in orderto control the target area so that certain procedures, such as forming astaple line, can be performed.

Still referring to FIG. 1, the retractor section 20 is connected to ascope tube 22 forming at least a portion of the working lumen 18 whichis connected to a handle portion 24 at the proximal end 14. A protectivesheath 23 may also be disposed over the scope tube for protectionagainst injuring the esophagus and related tissue while maneuvering thedevice down the esophagus to the stomach. The scope tube may be flexiblewith a bendable shaft made of resilient plastic such as polyurethane,silicone, PVC or a laminate, all optionally reinforced with a wire orbraid, or made of a composite construction of more than one material.Another option is that the scope tube can be articulable, such as beingformed of a slotted tube connected to a pull wire in the handle portion,to allow the operator to achieve flexion of any portion along the scopetube by operating the pull wire. The scope tube should be of sufficientlength to perform a procedure transorally in the stomach of the patient.In some embodiments, the scope tube may range from about 20 cm to about160 cm in length, and may range from about 5 mm to about 20 mm in outerdiameter. A preferable length of the scope tube is generally about 60cm, and a preferable outer diameter of the scope tube is about 18 mm.The length and diameter of the scope tube can vary depending upon theparticular application. The handle portion is used for holding thedevice and for maneuvering the retractor section.

As best shown in FIG. 2, one embodiment of the handle portion 24includes a frame 26, a handle grip 28, and a knob 30 for controlling alead screw 32 and nut 33 that is connected to a slider 34 for curvingthe retraction section into the retraction position. Pull cables 36 areattached to cable balance adjusting screws and extend through coil pipes37 along the scope tube and through the retraction section 20 to thedistal end 16 of the device 10. As shown in FIG. 1, the scope tube mayinclude organizer rings 38 that hold the pull cables and other wiresthrough the scope tube.

The handle 24 is intended to remotely actuate and hold the position of acable-actuated retractor. In use, the actuation relies on the relativetranslation of load between the cable 36 and the coil pipe 37 disposedaround it. When the cable is drawn through the coil pipe the cableshortens at the distal end 16 causing curvature of the retractor. Thehandle uses the lead screw 32 and nut 33 to translate the knob 30turning motion into axial translation of the load. The lead screwquality provides a mechanical advantage both so that the lesser inputloads are needed to actuate and to provide apposition holding ability sothat the handle may be released without relaxation of the retractorcurvature. The knob is fixed to the lead screw so that it allows anadvantage through the diameter of the knob to turn the lead screw. Whenthe lead screw is turned it drives the nut one way or the other. In onedirection the lead screw pulls the nut toward the handle and tensionsthe cable. In the other direction, the nut traveling away from thehandle, the tension is released and the retractor is relaxed. Arotational countering of the lead screw torque is provided by sliderbearings, located where the slider contacts the slide rails of the frame26. The lead angle of the screw helix is such that friction will notallow the lead screw to back drive under load and therefore the leadscrew is held in position.

The lead nut 33 is fixed to a traveler 39 which allows fixation of thepull cables 36. The pull cables may have crimps attached to their endswhich fit directly in crimp seats in the traveler, or the pull cablesmay pass through the traveler and seat in an adjustment screw to allowlength adjustment to the cable positioning. The pull cables may also bepassed under a washer and a screw head which fix the cables to thetraveler and allow fine tune positioning of the cable length.

The coil pipes 37 extend to the distal end of the scope tube 22 and areattached to coil balance adjusting screws 41 that allow for fine tuneadjustments to the length of the coil pipes to match the assembled shaftlengths. The resolving loads from the coil pipes are passed through theadjusting screws to the handle frame 26 and to the knob 30. Thus, a loadtensioning ability is provided between the cables and coil pipes.

In one embodiment, the retractor section 20 is a channel retractor 40(best shown in FIG. 4) and includes U-shaped link elements 42 that aredisposed adjacent one another between a proximal collar 43 a and adistal collar 43 b. A single U-shaped link element is shown in FIG. 3,and the link element includes a number of wire lumens 44. In thisembodiment, there are a number of spring element lumens 46 located nearthe center section of the link element, a pair of cable tension lumens48 located on opposite sides of the link element, and a pair of forcepslumens 50 located on opposite sides of the link element. It has beencontemplated that any number of lumens may be disposed at any locationon the link elements. The spring wire lumens may be filled with a springelement 52, such as at least one wire formed of a superelastic alloy,that biases the retractor section into the straight delivery position asshown in FIG. 1. The superelastic alloy may be nitinol or any othersuperlastic alloy. The spring elements can extend any length through thechannel retractor section and be unattached at the distal end, or theycan be attached at the distal end to the distal collar 43 b. The springelements can extend through the scope tube 22 to the handle portion 24at the proximal end 14, or they may only be attached at the proximalcollar 43 a of the channel retractor section. Pull cables 36 aredisposed within the cable tension lumens and are tensioned by turningthe knob 30 on the handle to curve the retractor section. The pullcables may extend from the handle 24 of the device and be attached tothe distal collar 43 b. The forcep lumens may house forceps that can beincorporated into the device. There are many types of forceps that areknown in the art, for example, biopsy forceps with alligator jaw made byOlympus, and any forceps meeting the required dimensions of the devicecan be used. The channel link elements may be made from a variety ofmaterials including clear polycarbonate or any other polymer that hasthe necessary strength, flexion, bondibility and biocompatibility. Inthis embodiment, only the wires and cables that are disposed through thelumens keep the channel link elements adjacent one another.

It also has been contemplated that cables may be used in place of thespring element 52 to return the channel retractor 40 from a curved orretraction position to a straight or insertion position. Instead ofusing a superelastic wire that biases the retractor section into astraight configuration, the cables (or cable) disposed through thespring element lumens 46 located near the center of the U-shape, can bepulled proximally by the operator to return the link elements to theinitial straight configuration. The retractor section can only bestraightened by the spring elements or cable after the pull cables 36have been loosened by the knob 30 at the handle 24.

In one embodiment, the distal end 16 of the elongated body 12 includesan atraumatic tip 54 to help prevent injury to the tissue inside anorgan such as the esophagus or the stomach. It is contemplated that theatraumatic tip can be a roller 56, or a shaped polymer tip 58 (see FIG.4B), or coiled tip similar to the construction of a guide wire as isknown in the art. The polymer tip can include a taper and/or a roundedshape. The roller or polymer tip can be connected through any methodknown in the art to the distal collar 43 b of the channel retractor 40.The tip can also terminate like that found on a commercially availableendoscope, such as the endoscope manufactured by Olympus with Model No.GIF-P140.

Referring to FIG. 4, the channel retractor 40 is shown in the deliveryposition with a roller 56 attached at the distal end 16. In the deliveryposition, the channel link elements 42 are designed and positioned nextto one another so that a wedge shaped gap 60 exists between adjacentchannel link elements. These wedge shaped gaps allow the channelretractor to curve into a retraction position when the pull cables 36are tensioned at the proximal end 14. FIG. 4A shows the channelretractor in a fully retracted position so that the wedged shaped gapsbetween the link elements are closed. In this position, the device canretract, block, push or move unwanted tissue away from a target area. Asthe channel retractor moves into the retracted position, the distal tipmay come into contact with and press against the stomach wall. Once inthe retracted position the arc of the channel retractor can be pressedagainst the stomach wall, thereby pushing and/or stretching the stomachwall. Also, the operator may push, pull, or rotate the device itselfwhile the channel retractor is deployed within the stomach to furthermaneuver the stomach wall, or to position the channel retractor into amore desirable position within the stomach. The channel retractor isalso shown in the retracted position in FIG. 4B, but in this embodiment,there is a shaped polymer tip attached to the distal end. After asurgical procedure is completed and it is desirable to return theretractor section to its straight delivery position in order to removethe device from the patient's body, the knob 30 on the handle portion 24can be turned to loosen the pull cables, and the biasing force of thespring element 52 returns the retractor section to its delivery orinsertion position. The cable tension wires can be adjusted to providethe desired curvature or arc of the retractor section. The arc formed bythe retractor in the retraction position may have a diameter in therange of about one inch to about sixteen inches.

FIGS. 5A through 5D show another embodiment of a channel retractor 40 a.As shown in FIG. 5A, a proximal channel link element 42 a is shown incross-section to include a boss 53 on one side of proximal link elementand an indentation 55 on the opposite side of the proximal link element.The proximal link element also includes a beveled face 51 a on theopposite end of the boss. An angle α of the bevel is shown to beapproximately 15°, however, the angle may range from about 5° to about25°. The higher the angle of the bevel, the more the retractor can curveas adjacent links bend or arc toward each other. Lumens 44, such ascable tensioning lumen 48 a and spring element lumen 46 a, are to bedisposed within the proximal link element, and the link element mayinclude multiple lumens disposed throughout the body of the linkelement. For example, there may be two lumens located through the linkelement on opposite sides of the boss and one lumen located through theboss (cable tensioning lumens), and one or two lumens located underneaththe boss (spring element lumens). FIG. 5B shows a distal link element 42b that is similar to the proximal link element 42 a except that thebeveled face 51 b includes an angle β. In the embodiment shown, angle βis approximately 8°, however, the angle may range from about 3° to about24°.

FIG. 5C shows the channel retractor 40 a including several proximal linkelements 42 a and several distal link elements 42 b joined together. Inone embodiment, there are ten proximal link elements and nine distallink elements, although the number of link elements may be varied toeffect the diameter of the retractor section in the retracted state. Thebeveled faces 51 a and 51 b create gaps 60 between adjacent linkelements. Because the angle of the beveled faces 51 a and 51 b aredifferent, the size of the gap between distal link elements is smallerthan the gap between adjacent proximal link elements. By tightening pullcables through the cable tensioning lumens 48 a and 48 b of the linkelements 42 a and 42 b, the pull cables actuate the retractor section byforeshortening the gaps between adjacent link elements, forcing theretractor section to curve into the shape shown in FIG. 5D. The angle ofcurvature of proximal section is greater than the angle of curvature ofthe distal section because of the different gap sizes between adjacentlink elements. Once in the retracted position, the bosses 53 of the linkelements are fitted within the indentations 55 of the adjacent linkelement. The boss is preferably tapered or rounded so that it does notlock within the indentation of the adjacent link element, which allowsthe boss to slide in and out of the indentation of an adjacent linkelement when the retractor is actuated into and out of the retracted orcurved position. The retractor section shown in FIG. 5D can bestraightened by pulling on a cable located in the spring element lumensor by allowing the biasing force of a spring element to return theretractor section to its straight delivery state.

The channel link elements 42, 42 a, and 42 b can also be disposedproximal of a tissue treatment device 300 to better position the tissuetreatment device inside the stomach cavity. FIG. 6 shows three channellink elements 42 positioned between the distal end of the scope tube 22and the proximal end of the tissue acquisition device. The device isshown within the stomach cavity (“SC”) near the lesser curve (“LC”). Thechannel link elements are positioned so that when actuated, they willbend and move the tissue acquisition device closer to or even in contactwith the lesser curve as shown in FIG. 6A. Any number of channel linkelements may be used for this purpose, and it is preferred that threelink elements be used. The channel link elements are actuated with apull cable as described above with respect to the channel link elements42, 42 a, and 42 b. A retractor section, such as the channel retractor40, may also be added to the distal end of the tissue treatment deviceas shown in FIGS. 6 and 6A, and the same pull cable may be used toactuated the proximal link elements at one end of the tissue treatmentdevice and the channel retractor at the other end of the tissuetreatment device. Alternatively, such angled sections of the device maybe configured with other types of linkages or hinge points, such as theflexible breach or bridge portion referred to as element 302 in FIG. 40,and further described in U.S. patent application Ser. No. 10/686,326 forapplication with similar therapeutic devices, previously incorporated byreference.

FIGS. 7 through 8A show another embodiment, where the retractor section20 is a split channel retractor 62. The split channel retractor includesa first section of link elements 64 and a second section of linkelements 66 that are attached together at a pivot 68. In the straight orinsertion position shown in FIG. 7, the first and second sections oflink elements are folded together in a side-by-side relationship. Inthis embodiment, the length of the retractor section during delivery maybe half of the length of the channel retractor 40, which may allow foreasier positioning and deployment within the stomach cavity. It ispreferred that the length of the first section 64 and second section 66be equal, wherein the pivot is in the middle of the retractor section,however, the two sections 64 and 66 may have unequal lengths as well.The channel link elements 70 of the first and second sections are bestshown in FIG. 7A and include an angled surface 71 and a flat surface 72,generally forming a D-shape. Also, at least one face of the channel linkelements 70 include a bevel at an angle between 2° and 25°, so that whenthe link elements are adjoined, a gap 60 between the link elements isformed. Several lumens are disposed through the channel link element,including an activation cable lumen 73 that carries an activation cable,a deactivation cable lumen 74 that carries a deactivation cable, andneutral axis lumens 75 that carry static cables to hold adjacent linkelements together. Referring again to FIG. 7, the split retractor isalso shown to have a soft tapered tip 75 to prevent injury to tissueduring the insertion of the device to the stomach. Further, theretractor is connected to a tissue treatment device 300 by an adaptertransition link 76 of the first section 64. In the split channelretractor's straight insertion state, the cables housed by the channellink elements are slackened so the split retractor is free to move inall directions during insertion of the device, allowing the retractionsection to freely navigate through tortuous lumens.

Referring now to FIGS. 8 and 8A, the split retractor 62 is activatedinto its curved shape by pulling an activation cable 79 in the proximaldirection. The activation cable crosses from the first section of linkelements 64 to the second section of link elements 66 at a pulley 77,and is crimped at an end cap 78 adjacent the distal most link element.The activation cable actuates the retractor by foreshortening angledgaps 60 between adjacent channel link elements 70 of the first andsecond sections 64 and 66, and by driving the pulley at the pivot 68. Toreturn the retractor to its straight delivery position, a deactivationcable 81, which mirrors the path of the activation cable within theretractor section, is tensioned proximally to act in the opposingdirection.

Another embodiment of the retractor section 20 is shown in FIGS. 9 and10. FIG. 9 shows a flat retractor 80 in the delivery position, and theflat retractor includes a first end 82 and a second end 84 with arounded tip. The flat retractor is formed from an elastomeric material,and is generally straight in the delivery position. Guide tubes 86 maybe formed into the elastomer of the flat retractor to carry spring wires88, such as nitinol wires, and possibly a supplemental wire which willbe discussed more below. The spring wires can extend any length down theflat retractor to bias the retractor into the straight delivery orinsertion position as shown in FIG. 9. An activation cable 89 isdisposed along the scope tube of the device and is attached to thesecond end of the flat retractor. The activation cable may be pulled ortensioned in the proximal direction to curve the second end of the flatretractor into an arc as shown in FIG. 10 to retract or block tissuefrom a target area. To return the flat retractor into its insertionposition, the activation cable is loosened, allowing the spring wires tobias the flat retractor into its straight position. It has also beencontemplated that the flat retractor may not need spring wires toposition itself in the straight position, because after loosening theactivation cable, the flexibility in the elastomer of the flat retractorwould allow the device to straighten as it is removed from the stomachand through the esophagus.

FIG. 11 shows another embodiment of retractor section 20 that is atubular retractor 90 having a first end 92 and a second end 94 that isrounded. The tubular retractor includes individual tubes 96 formed of aelastomeric material that can carry spring elements 98, such as nitinolwires, that bias the tubular retractor into a straight insertionposition. An activation wire 99 is attached to the second end of thetubular retractor and extends to the proximal end 14 of the device 10.The activation wire may be pulled or tensioned at the proximal end ofthe device to curve the second end of the retractor into an arc in orderto move unwanted tissue away from a target area or block unwantedtissue. To return the tubular retractor to its straight insertionposition, the activation wire is loosened, allowing the spring elementsto bias the retractor into its straight configuration.

In another embodiment, shown in FIG. 12, a bougie retractor 110 includesa cylindrical body 112 having a first end 114, a second end 116, and ataper 118. The cylindrical body is a tapered “bougie-like” body. It hasalso been contemplated that the bougie retractor includes a D-shapedbody 112 a as shown in FIG. 12A, so that one side of the body is flat.The bougie retractor is formed from a flexible elastomeric material,such as silicone rubber. In this figure, the first end is attached to aworking element or therapeutic device 119, such as a tissue treatmentdevice that is disclosed in U.S. patent application Ser. No. 10/797,303.The cylindrical body of the bougie retractor can be molded onto anadaptor 121 at its first end, so the retractor may more easily beconnected to the therapeutic device. Although not shown, a post can bewelded to the end of the therapeutic device that is advanced to areceiving hole in the adaptor, and a set screw can be used to lock theadaptor to the therapeutic device. In other embodiments, however, thedevice can be used without the working element 119 and the bougieretractor 110 may only be attached to the elongated body 12 of thedevice 10.

In one embodiment, an activation line 120 is attached to the cylindricalbody 112 of the bougie retractor near the beginning of the taper 118 asshown in FIG. 12. In other embodiments, the activation line may beattached to the second end 116 of the cylindrical body, or at any otherlocation along the cylindrical body. The activation line extends backalong the outer surface of the cylindrical retractor and extends to theproximal end 14 of the device 10 to the handle 24. Therefore, when theactivation line is tensioned or pulled in the proximal direction, thesecond end of the bougie retractor is curved back toward the first endto form an arc. This retraction position is shown in FIG. 12B. Theactivation line may also be attached to any location on the workingelement. In other embodiments of the bougie retractor, the cylindricalbody may not include a taper. Still in other embodiments, the second endof the cylindrical body may be rounded to better slide along the liningof the stomach when the retractor is curved.

Referring now to FIGS. 13-15, another embodiment of the retractorsection 20 is shown. In this embodiment, a bowed retractor 130 includestwo outer rods 132 and a central rod 134, all having a proximal end (notshown) (located outside of the patient when in use) and a distal end136. A collar 137 positioned near the distal end holds the rods inrelation to one another, and the central rod is allowed to slideproximally and distally through the collar. The distal end includes anatraumatic tip 138 that is connected to all three rods 132 and 134. Inone embodiment, the outer arms each include a flexible wire 140 disposedat the distal end and the flexible wires are covered by a sleeve 142.The flexible wire can be of any flexible material such as nitinol orstainless steel. The sleeve may also include vacuum ports along itslength and may be in fluid communication with a vacuum. FIG. 13 showsthe bowed retractor in its insertion position.

Once positioned within the stomach, the bowed retractor 130 can beactuated by pulling the central rod 134 in the proximal direction. Asthe central rod moves proximally, the flexible wires 140 of the outerrods 132 bend or bow outwardly with the outer rods remaining stationaryin the collar 137. This outwardly bowed shape is shown in FIG. 14. Inone embodiment, a vacuum can be created within the outer rods allowingthe vacuum ports located on the sleeve 142 to suction against tissuelining the stomach. The outer rods can then be rotated in one directionto each form an arc as shown in FIG. 15. In one embodiment, the bowedretractor is integrated with a therapeutic device (not shown). Thetherapeutic device can be positioned on the central rod so that when theouter rods are bent and rotated into an arc, the therapeutic devicewould be centered between the outer rods. The outer rods block unwantedtissue away from the therapeutic device, and also function to bringwanted or targeted tissue toward the jaws of the therapeutic deviceusing the vacuum ports. The bowed retractor can be returned to itslinear insertion position by rotating the outer rods in the oppositedirection and then pushing the central rod distally to straighten theouter rods.

Another embodiment of the retractor section 20 is shown in FIGS. 16 and17. A loop retractor 160 is shown in the delivery position in FIG. 16and in the retraction position in FIG. 17. The loop retractor includes asingle tube 162 that is bent over itself, having first and second endsthat are located together at the proximal end 14 of the device 10, and aworking portion 164 (looped end) that may include suction ports 166.During delivery, the single tube is positioned within a sleeve 167 thattransports the single tube to the stomach. When the loop retractor is inthe retraction position, a vacuum can be created within the single tubeso that the working portion can suction onto the lining of the stomachwall in order to manipulate the tissue. The loop retractor is deployedinto a retraction position from the delivery position by moving thefirst end and/or the second end distally so that the working portion ofthe device moves out of the sleeve and is able to expand into a loopwithin the stomach. Once deployed and a vacuum has been created, thesingle tube can be pushed, pulled, or rotated within the stomach tomaneuver the tissue into a desired position. In use, the single tube isplace against the lining of the stomach before the vacuum is created sothat the suction ports attach to the stomach wall without desufflatingthe stomach cavity. A diameter formed by the working portion can rangefrom about 1 inch to about 8 inch. Also, a diameter of the single tubeshould range between about ⅛ inch to about ¼ inch. In yet anotherembodiment that is shown in FIG. 18, the loop retractor may include twotubes that form two loops once in the retraction position. The retractorsection shown in these figures may also retract tissue without using avacuum.

In another embodiment, a linear retractor 170 is shown in FIGS. 19 and20 integrated with a working element 172 such as the stapling devicedisclosed in U.S. patent application Ser. No. 10/797,303. The linearretractor includes at least one strut 174 and preferably two strutsthat, when deployed, retract tissue away or block unwanted tissue fromentering the working element, allowing a target area to be treated bythe working element. The working element may include a vacuum, andtherefore when this vacuum is created, the linear retractor can blockunwanted tissue from entering the working area of the working element.The struts include a distal end 176 with atraumatic tips 178, and aproximal end located at the proximal end 14 of the device 10. A workingportion 180 of the struts is located adjacent the distal end and has aslightly curved shaped as shown in the figures. The linear retractoralso includes a ramp 182 disposed proximal to the working element, and apivot bracket 184 that is pivotally attached to the ramp. The struts arepositioned between the ramp and the pivot bracket, and stops 186 aredisposed on the working portion of the struts distally of the pivotbracket. FIG. 19 shows the linear retractor in the delivery positionwith the working portion of the struts positioned relatively close tothe working element to form a low profile for advancement through theesophagus. To actuate the linear retractor into the retraction positionas shown in FIG. 20, the proximal end of the struts are pulled in theproximal direction so that the stops of the struts engage and move thepivot bracket in the proximal direction. This allows the working portionof the struts to move away from the working element and into theretracted position. The position of the linear retractor is reversed bypushing the struts in the distal direction so that the stops move awayfrom the pivot bracket, allowing the working portion to return to itsdelivery position close to the working element.

An arm retractor 187 is shown in FIGS. 21 and 22 integrated with aworking element 172. The arm retractor includes two rods 188 havingcurved section 189 near the distal end. The rods are held relative toone another at the distal end by a collar 190. As shown in FIG. 21, theretractor is in its delivery position with the curved sections of therods positioned underneath the working element. It is also possible thatthe rods can be positioned on top of the working element during deliveryof this integrated device so long as the overall profile is low enoughto advance the device through the esophagus. Once the device ispositioned within the stomach, the rods can be rotated at their proximalends to rotate the curved sections away from the working element asshown in FIG. 22. In this position, the rods move unwanted tissue awayfrom the working element and also block unwanted tissue away from theworking element. After the working element performs a therapy on thetarget tissue of the stomach, the proximal ends of the rods can berotated in the opposite direction to return the curved sections to theworking element so the entire integrated device can be removed from thestomach.

There are also several types of vacuum retractors that can be used asthe retractor section 20. In one embodiment shown in FIG. 23, anarticulating vacuum 191 includes a tubular body 192 with a proximal end(not shown) and a distal end 194 and also includes vacuum ports 196 nearthe distal end that can be used to help retract tissue within thestomach. The number of vacuum ports can vary, and may only include oneport at the distal end. The articulating vacuum has the articulatingcapabilities of an endoscope, which is known in the art. In thisembodiment, a vacuum can be created within the tubular body so that thevacuum ports at the distal end can suction onto the stomach tissue, andthen the articulating vacuum can be maneuvered to reposition the stomachtissue, by pushing, pulling, folding, or twisting the stomach tissue.FIG. 23 shows the greater curve of the stomach being pushed away orstretched by the articulating vacuum. It has also been contemplated thatto form another embodiment of the articulating vacuum retractor, anendoscope can be used that includes a sleeve placed over the endoscope,wherein the sleeve includes vacuum ports and the space in between theendoscope and the sleeve can be connected to a vacuum. An advantage ofusing an endoscope to retract tissue is that the target area beingoperated on can also be viewed by the operator. In another embodiment,an endoscope alone can be used to retract or block stomach tissue fromthe working element.

FIG. 24 depicts another vacuum-type retractor. In this embodiment, acoaxial vacuum retractor 200 includes a tubular body 202 having aproximal end and a distal end 204, and a vacuum pod 206 located at thedistal end that translates relative the tubular body. As shown, thereare a plurality of vacuum ports 208 located at the distal end of thetubular body and at the vacuum pod, although only one vacuum port isneeded at the vacuum pod. This retractor can articulate similar to anendoscope, and the vacuum pod can be moved relative to the tubular bodyby a rod 210 that is controlled at the proximal end 14 of the device.Once the distal end is within the stomach cavity, a vacuum can beapplied to suction the stomach wall to the vacuum ports, and then thetubular body can be maneuvered to reposition the stomach tissue. Thisretractor also has the capability to smooth the lining of the stomachwall by removing wrinkles formed by the rugae of the stomach. The vacuumpod can be translated by pushing or pulling the rod, thereby allowingthe coaxial vacuum retractor to tension or stretch desired sections ofthe stomach tissue. For example, the vacuum pod may be deployed toacquire tissue along the lesser curve of the stomach and then extendedto apply axial tension to that region, thereby allowing a therapeuticdevice to be properly positioned, and also tensioning and smoothing outthe target region.

Referring now to FIG. 25, in yet another embodiment, a circular vacuumpod retractor 212 includes a vacuum pod 214 attached to the distal end216 of an articulating tube 218. The vacuum pod includes a plurality ofvacuum ports 219 disposed at least partially around the circumferentialouter surface of the pod. The vacuum ports may only be disposed on oneside of the pod, or they may be disposed around the entire outer surfaceof the pod. Further, only one vacuum port may be required on the vacuumpod. With all of the maneuvering capabilities of an articulatingendoscope, the articulating tube is able to flex and curve in multipledirections. In operation, when the distal end of the articulating tubeis positioned within the stomach, a vacuum in fluid connection with thevacuum ports can be created to suction stomach tissue into the vacuumports. The circular vacuum pod retractor can then be pushed, pulled orarticulated in any direction to maneuver the stomach tissue into adesired position.

In another embodiment, a translating vacuum retractor 220 is shown inFIG. 26. The translating vacuum retractor includes a tubular body 222along with a handle 224 at a proximal end, a cone-shaped pod 226 and acylindrical pod 228 at a distal end. The cylindrical pod is disposed ona rod 230 that slides within the tubular body to translate thecylindrical pod relative the cone-shaped pod. In this embodiment, thecone-shaped pod includes several vacuum ports on its outer surface, andthe cylindrical pod also includes vacuum ports on its outer surface. Theouter shapes of the pods 226 and 228 can be altered without changing thescope of the invention, and only one vacuum port is required on each ofthe pods. Further, in another embodiment, the pods 224 and 226 may bereversed along the tubular body, so that the cone-shaped pod is at thedistal end and translates on the rod relative to the cylindrical pod.The translating vacuum retractor can be used to push, pull or stretchthe stomach tissue. In one embodiment for its use, FIG. 27 shows thetranslating vacuum retractor in position within a stomach, such that thecone-shaped pod is positioned near the gastroesophageal junction (“GEJ”)and the cylindrical pod is positioned below the GEJ. A vacuum can becreated so the stomach lining is suctioned to the vacuum pods, and thecylindrical pod can then be translated away from the cone-shaped pod tostretch the cardia of the stomach. This will better enable a therapeuticdevice to perform a therapy in the vicinity of the GEJ of the stomach.

In another embodiment, a tissue tensioning retractor 240 is shown inFIGS. 28 and 29, positioned along a therapeutic device 241, such as thedevice disclosed in U.S. patent application Ser. No. 10/797,303. Thetissue tensioning retractor includes a platform 242 with a slidingsurface 244 and a lip 246 at a distal end. Attached to the platform is afirst pod 248 that is fixed, and a second pod 250 that translatesrelative to the first pod along the sliding surface of the platform.Each pod 248 and 250 includes one or a plurality of vacuum ports 252,and each is connected to its own vacuum line 254. The pods in thisembodiment are rectangular in shape, however, other shapes such ascircular, square, triangular or polygonal can be used as well. Further,in another embodiment, the first pod could also be movable along thesliding surface of the platform. In use, the tissue tensioning retractoris positioned within the stomach, such that the sliding surface isagainst the lesser curve of stomach, the first pod may be positionedabove the lower esophageal sphincter (“LES”), and the second pod may bepositioned below the LES. Once in position, a vacuum is applied to thefirst pod for grasping adjacent tissue above the LES, and a vacuum isthen applied to the second pod which grasps adjacent tissue below theLES. The second pod can then be translated axially, thereby stretchingthe region of the stomach tissue and removing any wrinkles along thelining of the stomach. The therapeutic device can then provide therapyto a smooth target section of the stomach. In certain embodiments, thetotal length of translation along the sliding surface can be up to 4inches. Preferably, the total length of translation between the firstand second pods is about 1 to 3 inches. In addition, positioning thefirst pod can also act to stabilize the therapeutic device against thetarget region (lesser curve) to assist in creating a fastening line thatis close to the targeted region (lesser curve) instead of flaring orangling away from the region.

A wire retractor 260 can also be used to push unwanted tissue from atarget area. The wire retractor is shown in FIGS. 30 and 31 attached toa tissue treatment device or working element 262 having an optionalseptum 264. A first end 266 of the wire retractor is attached to theseptum of the working element and the remaining wire is looped aroundthe working element and through the scope tube 22, where a second end(not shown) is positioned at the proximal end 14 of the device. Thefirst end may be attached anywhere along the working element includingthe hinge. In use, when the retractor and working element are passedinto the stomach, the second end of the wire retractor is pusheddistally as the first end is anchored to the working element, allowingexcess wire 268 to form a loop 270 or other space occupying geometrywithin the stomach cavity. In this retraction position as shown in FIG.31, the wire retractor pushes or blocks unwanted tissue away from theworking element. In some embodiments, the wire retractor is a nitinolwire, although any material, including stainless steel, can be used toform the wire. The wire retractor may also be used without beingintegrated with a working element or the septum element. It has alsobeen contemplated that the wire may have a circular cross-section or arectangular cross-section, such as a flat ribbon. In addition, aplurality of wires may be used to create a structure around the workingelement.

Other forms of wires can be used to retract tissue within a cavity. Inone embodiment, as shown in FIG. 32, a T-shaped wire retractor 280 canbe inserted and deployed within the stomach into a T-shape or anchorshape to present a target area of tissue for therapy. The T-shaped wireretractor includes an insertion rod 282 that is attached to a flexiblerod 284 at a pivot 286 at the distal end of the insertion rod. Duringinsertion, the flexible rod is pivoted to follow the position of theinsertion rod, so that the retractor resembles a single straight rod.Once in the stomach, the flexible rod will pivot as its end comes intocontact with the stomach wall, forming a T-shape with the insertion rod.The flexible rod could be deployed with cables or wires that could beretrievable or could remain within the stomach and along the esophagusto be used as a guide wire for insertion of a working element. Inanother embodiment, the flexible rod could deploy when its distal endcomes into contact with the greater curve GC of the stomach, forcing theflexible rod to pivot on the insertion rod. As shown in FIG. 32, theT-shaped wire retractor is deployed within the stomach, and the flexiblerod has pivoted away from the rod to form a T-shape or anchor shape thatdefines the greater curve of the stomach. Once deployed, the insertionrod may be pushed, pulled, or twisted to stretch the stomach tissue ormove the stomach cavity in a more desirable position. To return theT-shaped wire retractor to its insertion configuration, a pull wire maybe used to rotate the flexible rod on the pivot until the flexible rodis in-line with the insertion rod.

As previously discussed, an endoscope can be used to retract tissue, andanother embodiment of an endoscope used as a retractor is shown in FIG.33. This retractor is an endoscope 290 having a tubular body 292 with adistal end 294, and also includes retraction hoop or hoops 297 attachedto the tubular body. The retraction hoops each have a first end 295 anda second end 296 that are fixed anywhere around the tubular body of theendoscope. In the retraction position shown in FIG. 33, the endoscope isadvanced into a retroflex position and the retraction hoops are actuatedso that each forms a hemi-spherical configuration, thereby retractingunwanted tissue away from a target area near the therapeutic device 298shown in the figure. An actuating cable 299 is attached to the distalend of the endoscope and to each retraction hoop, so that when theendoscope actuates into the retroflex position, the actuating cablepulls the retraction hoops into a hemi-spherical configuration.Preferably, this retractor includes six retraction hoops, although theremay be anywhere from two to twelve retraction hoops positioned on oneside of the endoscope or on opposite sides of the endoscope. Theretraction hoops may be formed of a resilient polymer, NiTi, stainlessor other resilient or formable biocompatible material. These retractorsmay be independent of the scope or other wire structures, i.e. beadapted to be separately deployed.

Integrated Retractors

All of the retractor embodiments described above can be integrated withother devices, such as endoscopes, therapeutic devices or workingelements, vacuums, suction cups, graspers, and even other secondaryretractors. The working element shown in the figures is the tissuetreatment device disclosed in U.S. patent application Ser. No.10/797,303, however, any other gastroplasty device can also beintegrated with the retraction devices.

Referring now to FIG. 34, the device 10 is modified by attaching orintegrating a tissue treatment device 300 to the distal end of the scopetube 22 with struts 302 that may be flexible both to assist in passageof the scope, and also to assist positioning the tissue treatment devicein the desired location relative to the targeted tissue. The retractorsection 20 is attached to the distal end of the tissue treatment deviceby a transition section 304, which may be inverted U-shape channel linkelements or other flexible or resilient construction to assist theretraction function. In this embodiment, the transition section isdesigned such that an endoscope 306 may be advanced through the scopetube, under the tissue treatment device, and through a port 308 createdby the transition section to be positioned within the channel formed bythe link elements 42 of the channel retractor. In this position, whichis shown in FIG. 34, the endoscope is able to view the tissue treatmentdevice during the surgical procedure. A secondary retractor 310 may alsobe integrated with the retractor section. This embodiment includes asupplemental wire retractor 312 or antrum retractor that can be retainedwithin a groove 314 formed along the outer surface of the link elements.A distal end of the supplemental wire retractor is attached to thedistal end of the channel retractor, and a proximal end of thesupplemental wire retractor is located at the proximal end of thedevice. In use, the supplemental wire retractor can be pushed in adistal direction to leave the groove and expand into a retractionposition in order to retract additional stomach tissue. Once theprocedure has been completed, the supplemental wire retractor can bepulled proximally, returning it to the groove of the channel retractor,and the channel retractor can then be returned to its straight deliveryposition as described above. The endoscope can then be removed from thebody of the patient, followed by removing the integrated device 10.

FIG. 35 shows another embodiment of the integrated device including thetissue treatment device 300 attached to the distal end of the scope tube22 by a breach portion shown as struts 302 that may be able to move thetissue treatment device relative to the scope tube. It is contemplatedthat such a breach portion may also be formed by a molded part, casingor other housing to ensure a smooth transition of the scope or otherworking tool, while also preserving the atraumatic surfaces and overallflexibility of the device. In this embodiment, the channel retractor 40is attached to the distal end of the tissue treatment device by a pin316 that extends distally from the tissue treatment device. The channelretractor includes a connecting ring 318 that locks onto the pin. A bore320 is disposed through the connecting ring so that the endoscope 306can be advanced into the channel of the channel retractor. In thisembodiment the bore extends through the center of the connecting ring.Similarly, any type of retractor, such as the bougie retractor, may beused instead.

An endoscope 306 also can be advanced into the channel of the channelretractor 40 when a bore 320 is disposed through the connecting ring asshown in FIG. 36. In this embodiment, the endoscope is advanced from theproximal end of the tissue treatment device and is then maneuveredthrough the bore into the channel. It is also within the scope of theinvention to insert an endoscope or other working device alongside theretractor element in the event that the retractor does not have achannel or other cooperating feature.

Referring now to FIGS. 37 and 38, the flat retractor 80 is attached tothe distal end of a tissue treatment device 300. The flat retractor canbe attached to the tissue treatment device by using a set screw or a pinthat latches the retractor to the tissue treatment device. Thisintegrated device may also be used with an endoscope, a supplementalretraction wire 312, or any other secondary device. FIG. 38 shows a backview of the integrated flat retractor, and a bore 324 disposed throughthe proximal end of the flat retractor. This bore can allow an endoscopeto be positioned on the front side of the flat retractor to view thetissue treatment device and the working area surrounding the tissuetreatment device. It is also contemplated that the endoscope can beadvanced through the scope tube 22 of the device and then be articulatedto view the tissue treatment device from the side of the flat retractor.Also shown in FIG. 38 is the supplemental retraction wire positionedwithin a groove 326 along the backside of the flat retractor. Asdescribed above, the supplemental retraction wire can be deployed bysimply pushing the wire in the distal direction, and the supplementalretraction wire can then be clamped or held outside the patient's bodyat the proximal end to hold the supplemental retraction wire in theretracted position.

Next, an integrated version of the bougie retractor 110 is shown in FIG.39. As shown, the bougie retractor is attached to the distal end of thetissue treatment device 300. The bougie retractor operates in the mannerdescribed above, with the septum line or activation line shown as adotted line. Similar to the integrated channel retractor, in thisembodiment the tissue treatment device is attached to the distal end ofthe scope tube 22 by breach or bridge shown as flexible struts 302 thatallow the tissue treatment device to be moved relative to the scope tubein order to provide space for an endoscope 306 to be advanced along thebackside of the tissue treatment device. A sleeve 301 or other guide maybe attached to the backside of the tissue treatment device to cradle orcontain the endoscope or retractor device that may be inserted alongsidethe device. This feature may also prevent the scope from torquing or“wowing” in a variety of directions that may impact the resultinggeometry of the gastroplasty or pouch. The sleeve may be made of anyflexible material and may be any length along the tissue treatmentdevice. FIG. 40A shows a cross-sectional view taken along line 40A-40Aof FIG. 40, showing the endoscope positioned within the sleeve 301. Theendoscope can be used to view the tissue treatment device and theadjacent working area of the stomach by being retroflexed on the side ofthe bougie retractor as shown in FIG. 39. Although not shown in thisfigure, a supplemental wire retractor also can be integrated within agroove disposed along the bougie retractor.

Another embodiment of the integrated bougie retractor 110 is shown inFIG. 40, and at least a portion of the cylindrical body 112 is carvedaway to form an indentation 330 so that the endoscope 306 can moreeasily view the tissue treatment device. The indentation formed in thesurface of the bougie retractor can be of varying depths and lengthswithout effecting the integrity of the bougie retractor.

Referring to FIG. 41, an endoscope 306 is shown in conjunction with atissue treatment device 300. The endoscope is resting adjacent oralongside the tissue treatment device and is flexed to retract unwantedtissue away from the tissue treatment device and to view the tissuetreatment device. FIG. 41A shows another embodiment of the tissuetreatment device, in which the optional septum 332 of the tissuetreatment device is hinged to the tissue treatment device at the distalend, so that after tissue within the stomach has been acquired, theseptum can be moved away from the working area to allow the tissuetreatment device to form a staple line along the stomach lining. Theseptum can be moved away from the working area by using a pushing rod ora pull wire. Further, the struts 302 connecting the tissue treatmentdevice to the scope tube may be rotatable to axially misalign the tissuetreatment device relative to the scope tube. Other embodiments of theseptum and tissue acquisition device can be seen in U.S. Pat. No.6,558,400, which issued May 6, 2003, and U.S. patent application Ser.No. 10/797,439, which was filed Mar. 9, 2004, which have already beenincorporated by reference.

Another embodiment is shown in FIGS. 41B and 41C, where an optionalseptum 333 is integrated with a retractor, such as a wire retractor 260a. FIG. 41B shows the wire retractor having two resilient wires (e.g.nitinol wires) attached to the septum. The septum is connected to thetissue treatment device 300 by a pin (not shown) or other means. In thisembodiment, the wires may be pushed distally to form a loop within thestomach cavity to push or block any unwanted tissue away from the tissuetreatment device. During the tissue treatment procedure, the septum isremoved to allow the tissue treatment device to acquire the tissue, byfirst releasing the pin connecting the septum to the tissue treatmentdevice. Then, the resiliency of the wires flips the loose septum awayfrom and out of the tissue treatment device as shown in FIG. 41C. It hasalso been contemplated that the wire retractor 260 a can only be used toremove the septum from the tissue treatment device.

Another embodiment is shown in FIGS. 42 through 42B, with a tissuetreatment device 300 integrated with a modified bougie retractor 450. Inthis embodiment, the tissue treatment device includes a fan septum 452having a first blade 454, a second blade 455, and a sheet 456, such as aplastic film. The sheet is attached to an edge of the first blade and anedge of the second blade. There is a removable pin that joins the secondblade to the tissue treatment device. Distal ends of the first andsecond blades are attached to the distal end of the tissue treatmentdevice at a pulley 458. There is also a pull cable 460 that attaches tothe pulley, and when pulled raises the septum into a retractionposition. The modified bougie retractor includes a slot 462 that isdisposed and sized for receiving the fan septum.

FIG. 42 shows the device in the delivery position, with the fan septum452 positioned within the tissue treatment device. Once positioned inthe stomach, the jaws of the tissue treatment device are opened, and thepull cable 460 is pulled proximally to turn the pulley and raise thefirst blade 454 of the fan septum as shown in FIG. 42A. In thisposition, the sheet 456 is stretched between the first and secondblades. The first blade can be raised to an angle that is determined bythe size of the sheet. Tissue can be acquired by the tissue treatmentdevice while the first blade is in a raised position to assist ingathering tissue. After tissue has been gathered, the releasable pin canbe removed to release the proximal end of the second blade, and the pullcable 460 can then be pulled to swing both the first and second blades,along with the sheet, into the slot 462 of the modified bougie retractor450 as shown in FIG. 42B. The jaws of the tissue treatment device arethen closed so the integrated device can be removed.

FIG. 42C shows another embodiment of a tissue treatment device 300having a multi-blade fan septum 470. The multi-blade fan septum includesa plurality of blades that are slidably joined together to fan out whenin a raised position. The distal end of the blades are attached to apulley 472 disposed in the tissue treatment device. There is a proximalfan blade 474, which is raised first, and a distal fan blade 476 that isattached to the tissue treatment device by a releasable pin. Any numberof blades may be between the proximal and distal blades, and thepreferred embodiment includes a total of five blades including theproximal and distal blades. Once the device is positioned within thestomach, the jaws of the tissue treatment device are opened, and a pullcable 478 that is attached to the pulley 472 is pulled proximally toraise the blades of the multi-blade fan septum. The proximal blade israised only to a position allowed by the other blades which fan out.After tissue is acquired, the releasable pin can be removed to free thedistal blade, and the pull cable can be pulled proximally to swing themulti-blade fan septum into a slot 480 of a modified bougie retractor482. The slot is sized to house the multi-blade fan septum. When theblades are secured within the modified bougie retractor, the jaws of thetissue treatment device can be closed, and the integrated device is thenremoved from the patient.

The device 10 along with the different embodiments of the retractionsection 20 can be integrated with secondary retractors, such as asupplemental wire retractor, endoscopes to view the working area, andtissue treatment device to perform a therapy to the target area. Otherdevices can also be incorporated with retraction device. For example, asshown in FIG. 43, a flat band spreader 340 may be used to move thestomach tissue into a position that is more useful for advancing theretractor device 10 or tissue treatment device into the stomach cavitywithout pushing into the stomach wall. The flat band spreader includes aflat band 342 that has a normal bent configuration resembling a loop 344with a pointed end 346 as shown in FIG. 43. It is possible that the bentconfiguration of the flat band can resemble any other geometry as well.An elongated tube 348 is used to house the flat band for delivery intothe stomach. The cross-section of the flat band is rectangular in shapeas shown in FIG. 43A. A handle 350 is attached to the proximal end ofthe flat band and is used for deploying and retracting the flat band. Inuse, the elongated tube, sized such that it fits within the lumen of thescope tube 22, is advanced through the retractor device and into thestomach, where the handle can be pushed in a distal direction to advancethe flat band out from the elongated tube, allowing the flat band totransform into its normal bent configuration. It is also possible forthe elongated tube to be pulled proximally allowing the flat band toresume its bent configuration. The loop of the flat band shouldreposition the stomach, allowing the retractor device to further advanceinto the stomach. The flat band spreader can also be used to retract thestomach tissue to help a tissue treatment device acquire desired tissue.

Another type of secondary retractor that can be incorporated into any ofthe embodiments of the retractor devices is a grasping forceps retractor360. Referring to FIG. 44, the channel retractor 40 is shown as anexample of how the grasping forceps can be incorporated into the device.In this embodiment, the grasping forceps retractor includes an elongatedtube 362 that houses a cable, and forceps 364 connected to the cable andlocated at the distal end of the elongated tube. In this embodiment, apair of grasping forceps retractors extend through the scope tube andinto separate forceps lumens 50 of the channel link elements 42, andeach exits at an angle to the distal end of the retractor section. It ispreferred that the grasping forceps retractors extend from the channelretractor so that they are aimed at the sides of the tissue treatmentdevice 300. Once the channel retractor is in the retraction positionwithin the stomach, the elongated tube of the grasping forceps can bemoved in the distal direction to extend the forceps from the channelretractor so that the forceps come into contact with tissue located nearthe tissue treatment device. The cable extending through the elongatedtube is used to actuate the forceps to grab onto tissue, and theelongated tube can then be pulled in the proximal direction to pull anddrape surrounding tissue onto the tissue treatment device. Although thisembodiment is described as being incorporated with the channelretractor, the grasping forceps retractor can be incorporated with anyof the retraction devices previously described.

In another embodiment, a secondary retractor includes suction vacuumcups that extend from a retractor section and are used to grasp tissuein a similar manner described above with the grasping forceps retractor360. The suction vacuum cups are disposed at the distal end of a vacuumtube and are maneuverable within the stomach to extend from a retractorsection, such as the channel retractor, and grasp tissue that can thenbe pulled toward the tissue treatment device.

Using vacuum ports or suction cups along or within any of theembodiments of the retractor section has also been contemplated. Thevacuum ports or suction cups allow any of the retractor sections tograsp onto the stomach tissue and move tissue from the target area to atissue treatment device, after the retractor section has blocked ormoved unwanted tissue away from the target area.

Additional Retraction Devices and Methods

Other retraction devices can be used in place of or in combination withthe retractor device 10 described above to accomplish the same goal ofmoving or keeping unwanted tissue away from a target area or smoothingthe stomach tissue. One method of retracting the stomach tissue is byuse of insufflation alone. Using this technique, the stomach cavity isinsufflated by blowing a gas therein to expand the stomach. Insufflatingthe stomach expands the stomach cavity which smoothes out any folds orwrinkles that may be found within the stomach. After insufflation, thesmooth stomach wall can then be acquired by a tissue treatment device toperform a therapy without acquiring folds or wrinkles, which may beundesirable. Also, insufflating the stomach cavity allows a retractordevice to more easily maneuver into the stomach and actuate into theretraction position. In some embodiments the stomach is desufflatedbefore acquiring tissue with the tissue treatment device, and theretractor device would then block unwanted folds of tissue from reachingthe tissue treatment device after desufflation.

There are several other embodiments for expanding the stomach to retractor smooth the stomach wall. One embodiment is to insert a formed wire370 into the stomach that takes on a predetermined shape once it isinserted into the stomach cavity to hold tissue away from a target area.The formed wire can be nitinol that has a predetermined shape. Toadvance the formed wire into the stomach, a tube 371 can be used tohouse the formed wire, which is then advanced to the stomach. Once thetube reaches the stomach, the formed wire can be advanced out of thetube to resume its predetermined shape. For comparison reasons, FIG. 45shows an illustration of an empty stomach, and FIG. 46 shows thecross-section of the stomach taken along line 46-46 of FIG. 45.Referring now to FIG. 47, a form wire is shown deployed within thestomach, and FIG. 48 shows the cross-section of the stomach taken alongline 48-48 of FIG. 47. When the form wire is deployed within the remnantvolume, the cross-section of the stomach is forced into a lenticular, orpancake shape, bringing the anterior and posterior sides of the stomachcloser together, which allows a tissue treatment device to betteracquire and perform a therapy to a target area. By stretching thestomach, any wrinkles or folds found within the stomach may also besmoothed out, allowing the tissue treatment device to acquire tissuefrom a target area without also acquiring wrinkles or folds from thestomach wall. To remove the form wire from the stomach cavity, the wireis simply pulled back into the tube and then removed from the body ofthe patient.

Other embodiments, like the one shown in FIG. 49 include inserting acoil 380 into the stomach to block tissue away from a target area inorder to allow a tissue treatment device to acquire preferential tissue.Similar to the above form wire embodiment, the coil is straightened andhoused in a tube 381 for advancement into the stomach. Once at thestomach, the coil can be deployed from the tube so that the coil resumesits natural shape.

FIG. 50 shows an embodiment that includes a kite retractor 382 having aframe 384 that resembles the shape of a kite when it is in the retractedposition. The frame includes four ends or points 386 that may includeclips 388 to grasp onto the stomach wall. This design would block tissueand allow the tissue treatment device to acquire preferred tissue.During insertion into the stomach, the frame of the kite retractor isfolded into a longitudinal body and advanced to the stomach via a tubeor catheter. Once in the stomach the kite retractor is deployed using apush rod to expand the frame of the kite retractor. The same push rod oreven pull cables may be used to attach the clips onto the wall of thestomach. In one embodiment, the kite retractor is expanded into thestomach after the stomach is first insufflated.

It has also been contemplated that the clips disposed on the kiteretractor 382 could be replaced with suction cups or even vacuum ports.When using vacuum ports, the frame 384 of the kite retractor wouldinclude a vacuum tube having vacuum ports for suctioning onto thestomach wall. In the embodiment shown in FIG. 51, the kite retractorincludes a vacuum tube 392 surrounding the frame of the kite retractor,with several vacuum ports 394 located around the vacuum tube. In thisembodiment, once the kite retractor has been deployed within thestomach, a vacuum can be created within the vacuum tube, so that thevacuum ports suction onto the stomach wall. These devices can all beinserted into the stomach while it is insufflated. Then, beforeacquiring tissue for treatment by the tissue treatment device, thestomach can be desufflated and the retraction devices will then blockunwanted tissue from the tissue treatment device.

Yet another embodiment is the use of a balloon 410 to retract or blocktissue to achieve preferential tissue acquisition for creating a targetpouch. FIG. 52 shows a balloon catheter 411 with an expanded balloonthat is inflated on the front side of a tissue treatment device 300. Inthis embodiment, the balloon catheter is inserted into the stomachseparately from the tissue treatment device. In other embodiments, theballoon catheter may be attached to the backside of the retractorsection. Once the tissue treatment device is placed within the stomachnear a target area, the balloon can be inflated to hold tissue in placeor to block unwanted tissue from the tissue treatment device. Theinflated balloon expands the stomach and may even push the stomach wallalong the greater curve of the stomach away from the tissue treatmentdevice, thereby smoothing out any wrinkles or folds along the stomachwall. This allows the tissue treatment device to acquire tissue withoutacquiring wrinkles or folds.

In another embodiment, a bow retractor 420 can also be used to retracttissue within the stomach. Referring to FIG. 53, the bow retractorincludes a bowing tube 422 that is connected to an insertion rod 424.The bowing tube includes a proximal portion 426 that is disposed aroundthe insertion tube, and a bowing portion 428 found at the distal end.The bowing portion does not surround the insertion rod and is onlyattached to the insertion rod at the distal end. It is noted that thebowing portion and proximal portion are in fluid communication with oneanother. The bowing portion forms a semi-circle when deployed, and thebowing portion may include suction ports 430 so that a vacuum can beapplied. To deploy the bowing portion, the rod is pulled proximally,shortening the distance between the distal end of the bowing portion andthe proximal end of the bowing portion. In this position, the bowingportion is able to retract tissue and block any unwanted tissue from atissue treatment device.

Placing these above-described devices into the remnant volume of thestomach blocks or retracts tissue within the stomach, and even thins orsmoothes out any wrinkles or folds found in the tissue. By retractingthe stomach tissue in such a way, a tissue treatment device is assistedin forming a pouch within the stomach as taught by the aboveincorporated references. The retraction helps achieve preferentialtissue acquisition by the tissue treatment device. It should beunderstood that these devices can also be incorporated within orattached to the tissue treatment device, and can be used in combinationwith the retraction devices described earlier.

The gastroplasty device or tissue treatment device could also be alteredto retract or block tissue from the opening of the tissue treatmentdevice. As shown in FIGS. 11A through 11D of U.S. patent applicationSer. No. 10/797,303, which already has been incorporated by reference,the septum of the gastroplasty device can include a septum member and aperpendicularly positioned transverse septum member, which may extendpartially over the openings when the cartridge member and anvil memberare in an open configuration. As shown in FIG. 54, the tissue treatmentdevice 300 includes a cartridge member 440 and an anvil member 442, anda septum 443 that includes a transverse septum member or hood 444 thatextends over the opening between the cartridge member and the anvilmember. The hood attaches to the gastroplasty device in the same mannerthe septum does. When a vacuum is created within openings found in thecartridge and anvil members to suction tissue of the stomach wall, thehood acts to block unwanted tissue, such as folds or wrinkles, fromentering the vacuum openings of the cartridge and anvil members. Theshape and size of the hood may be varied to block more or less tissuefrom the gastroplasty device. For example, the hood may be formed morelike a “T” by eliminating the curved end sections of hood 444.

Yet another embodiment of a retractor section integrated with a tissuetreatment device is shown in FIGS. 55A through 55D. This embodimentincludes an axial retractor 500 having an actuation sleeve 502 thathouses two pre-shaped nitinol wire struts 504. Retractable anchors 506are attached to the distal end of the nitinol wire struts and mayinclude snares, graspers, or have suction capabilities to grab ontostomach tissue for manipulation. The nitinol struts are pre-shaped sothat they bend outwards when removed from the actuation sleeve as shownin FIG. 55B. In use the actuation sleeve is positioned along the side oftissue treatment device 300 during delivery. FIG. 55A shows theintegrated device being delivered to the stomach near the LES. Once atthe LES, the pre-shaped nitinol struts are pushed distally out of theactuation sleeve and they bend outward until the anchors come intocontact with the prolapsed tissue of the stomach. The anchors grasp ontothe tissue and can be used to further push or retract the stomachtissue. The nitinol struts can also be pulled proximally within theactuation sleeve, so that the tissue is brought closer to the tissuetreatment device as shown in FIG. 55C. After the tissue is broughttoward the tissue treatment device, the actuation sleeve can be pusheddistally to move the tissue acquired by the anchors distally, removingany wrinkles in the prolapsed tissue of the stomach. FIG. 55D shows thewrinkles of the stomach tissue removed and the tissue treatment deviceadvanced into position to perform a therapy.

The retractor devices described above, either separate or integrated,can perform several functions. First, the retractor devices pull away,block or otherwise manage rogue tissue, mainly excess fundus tissues,from being involved in the tissue treatment device. Also, the retractiondevices organize the targeted tissue by flattening or removing wrinklesand sub-folds from the desired lip folds. Then the targeted tissue canbe suctioned into or brought to members of the tissue treatment devicefor therapy. Any flattening of rugae is beneficial during the surgicalprocedure. Further, the retraction devices support the placing of thetissue treatment device within the stomach in the desired sleeve forminglocation. The retractor device can help move the tissue treatment devicecloser to the lesser curve of the stomach, or the retractor device canbe used to initially move the stomach to bring the lesser curve of thestomach to the tissue treatment device. Another advantage is that theretractor devices can retract or accommodate inter-abdominal pressurefrom weight of internal organs and abdominal wall. The retractor shouldbe strong enough to lift and bear the weight of internal organs or itcan orient the stomach in a direction that does not encounter suchloads. Yet another advantage is that by having a flexible element distalto the tissue treatment device, such as the bougie retractor describedabove, it helps the tissue treatment device pass tortuosity more easily.

Methods

The retraction devices described above can be used in combination with atissue treatment device to provide therapy to the stomach of a patient.In general terms, a retraction device along with a tissue treatmentdevice can be inserted transorally to the stomach. Some embodimentsinclude an integrated device where the retraction device and the tissuetreatment device are integrated together into a single unit to simplifythe surgical procedure. In embodiments where an endoscope is being usedto view the stomach cavity, the endoscope can be initially loaded withinthe scope tube of the device, or may be placed separately alongside thedevice, or initially loaded within the tube and then directed outsidethe device body to maximize visualization/retroflexing of the scope.Although not required, it is preferred that the stomach be insufflatedbefore advancing the device into the stomach. Once in the stomachcavity, the endoscope can be retroflexed to about 180°-270° so that itsdistal end is directed back towards the scope tube to view the tissuetreatment device. When the devices or the integrated device is correctlypositioned within the stomach, the retraction device can be deployed orretracted to move, push or pull portions of the stomach tissue away froma target area near the tissue treatment device to allow a surgicalregion of the stomach to be approximated for treatment. The retractorsection is actuated using the handle at the proximal end of the device.With unwanted wrinkles or folds retracted away from the tissue treatmentdevice by the retraction device and the area being viewed by theendoscope to assist the physician with the surgery, the stomach tissuefrom the target area can be acquired for treatment. In embodiments wherethe stomach is insufflated at the beginning of the procedure, thestomach is desufflated, usually by the suction force of the tissuetreatment device, as the tissue treatment device acquires theappropriate tissue. After the tissue is acquired, the jaws of the tissuetreatment device clamp together to form multiple tissue folds (a dualfold), and then staple the dual fold of tissue to form a sleeve stapleline 550 that is generally about 45 mm in length. The retraction sectionis then returned to a straight position so the integrated device can beremoved from the stomach cavity. Once the integrated device is removed,a single fold treatment device may then be inserted into the stomach toform a single fold plication 552 along the lesser curve of the stomach.The single fold plication is about 25 mm in length and is positionedalong the lesser curve of the stomach so that a distal stoma 554 isformed between the single fold plication and the dual fold staple line,that is about 10 mm in diameter. After stapling tissue along the lessercurve the single fold treatment device is removed and the stomach isleft reconfigured as shown in FIG. 56. The distal stoma can more easilybe seen in FIG. 56A, which is a cross-section taken along line 56A-56Aof FIG. 56. Depending on the desired tissue geometry and accuracy of theplacement of the single fold plication, the method can be repeatedallowing additional single fold plications to be placed within newlycreated tissue geometry.

A representative illustration of how the retractor device 10 and thetissue treatment device 300 are used together to treat a target areawill now be described. Referring to FIG. 57, the integrated retractordevice 10, including a retractor section 20 and a tissue treatmentdevice 300, is shown being advanced transorally through the esophagus(“ES”) of a patient and positioned within the stomach cavity (“SC”). Asdescribed in the incorporated references, the tissue treatment devicemay be articulated outside of the patient via a handle so that thedistal portion (portion farthest from the handle) of the tissuetreatment device may be positioned such that the spine of the device isplaced against a portion of lesser curvature (“LC”) and opposite greatercurvature (“GC”). In this way, the tissue treatment device extendsbetween the gastroesophageal junction (“GEJ”) towards pylorus (“PY”).The retractor section may also be articulated outside of the patient viathe handle 24 either before or after the tissue treatment device iscorrectly positioned.

FIG. 58 shows the retractor section, in this embodiment the bougieretractor 110, in a retracted configuration forming an arc within thestomach cavity. In this position the retractor section 20 blocksunwanted tissue or retracts unwanted tissue away from a target area sothe acquisition device 300 can acquire the desired tissue for staplingwithout gathering unwanted folds. An antrum wire 312 also is shown to bedeployed in FIG. 58. The antrum wire retracts additional stomach tissueaway from the tissue treatment device. The retractor can also bemaneuvered with the handle at the proximal end in any direction toadjust or move the tissue of the stomach. For example, the retractorhandle can be moved proximally, distally, or rotated, thereby causingthe retractor section to move and manipulate stomach tissue. Flexibleendoscope 306 is shown in FIG. 58, and may be placed alongside thetissue treatment device or can be advanced through the scope tube 22 ofthe retraction device, underneath the tissue treatment device and thenaround the side of the bougie retractor 110 to view the working area. Inan embodiment where the tissue treatment device includes vacuumcapabilities to suction desired stomach tissue into the members of thetissue treatment device, the retractors deployed within the stomachcavity will also block unwanted additional tissue from being suctionedto the tissue treatment device. Once the tissue treatment device hasperformed its therapy to the stomach wall (for example forming a stapleline), the endoscope can be removed to allow additional space to removethe tissue treatment device along with the retraction device. Theprocedure of performing a therapy to the stomach wall with a tissuetreatment device can be found in the previously incorporated references,such as U.S. patent application Ser. No. 10/188,547. Before removing theretraction device from the stomach cavity, the antrum retractor isreturned to its insertion position within a groove disposed on the bodyof the bougie retractor, and the bougie retractor is returned to itsstraight delivery position so that it can be withdrawn proximallythrough the esophagus.

The method described above can incorporate any of the retraction devicesand methods disclosed above. For instance, the stomach may also beinsufflated to provide a better viewing area with the endoscope and toassist in retracting any unwanted tissue. Further, a balloon may also beinflated on the back side of the retractor section to move additionaltissue away from the tissue treatment device. All of the embodimentsdisclosed are advantageous because they retract stomach tissue bymoving, pushing, pulling, or twisting unwanted tissue away from thetissue treatment device, allowing the tissue treatment device to moreeasily acquire target tissue and perform a therapy thereon.

FIGS. 59-63 show an embodiment of advancing the tissue treatment deviceto the stomach. In this embodiment, at the beginning of the tissuetreatment procedure, a loop 560, such as a suture or a ring, is attachedto the lesser curve of the stomach near the incisura. This loop can beattached directly to the stomach tissue, or a single fold may be formedby a tissue treatment device and the loop may then be attached to thesingle fold. A wire or thread 562 (suture) is passed through the loop560 with both ends of the wire 562 extending outside of the patient'smouth. With the wire acting like a guide wire similar to the function ofa guide wire in an “over the wire” cardiac catheter procedure as isknown in the art, a guide tube 564 is advanced over the wire, as shownin FIG. 60, until its distal end abuts the loop. The guide tube shouldbe flexible enough to maneuver through the esophagus to the stomach, butstill having enough stiffness to apply an axial force to the loop. Withthe guide tube in place, the tissue treatment device 300 is advancedalong the guide tube to the stomach cavity, as shown in FIG. 61.Although not shown in the figures, the tissue treatment device may beintegrated with a retraction device as well. Referring now to FIG. 62,once the tissue treatment device is in position within the stomach, anaxial force may be applied over the guide tube by pushing the guide tubeand pulling or holding steady the ends of the wire outside of the body.This action axially retracts the lesser curve of the stomach to removeany wrinkles along the lesser curve and assists in ensuring properplacement of the treatment device 300 against the lesser curve of thestomach. Tissue is then acquired by the tissue treatment device and astaple line 566 is formed within the stomach. After the procedure iscompleted, the tissue treatment device, guide tube, and wire areremoved, leaving the loop and the staple line in the stomach as shown inFIG. 63. The advantages of this embodiment are that the loop provides ananchor point for retracting the stomach tissue and helps align thetissue treatment device along the lesser curve.

In another embodiment, at the beginning of the tissue treatmentprocedure, a loop is attached to the lesser curve of the stomach nearthe incisura as described above. A retraction device or tube can then bepassed down into the stomach and a distal end of the retraction deviceor tube can be attached to the loop by a hook, grasper or similardevice. Once attached to the loop, the retraction device or tube can bepushed distally to axially retract the stomach tissue. A tissuetreatment device may then be passed along the retraction device or tubein order to help align the tissue treatment device with the lessercurve. This embodiment also provides an anchor point for retracting thestomach tissue and helps align the tissue treatment device along thelesser curve. Alternatively, instead of placing a ring or staple, thewire may employ small graspers at the distal end and may simply grasptissue and be used in the method described above. Following theprocedure, the graspers are released, and the entire wire assembly isremoved from the patient.

In yet another embodiment shown in FIG. 64, a catheter or wire 570having a balloon 572 disposed at the distal end thereof can be advancedinto the stomach until the balloon is oriented in the region of thepylorus (“PL”). The balloon is then temporarily inflated, therebyanchoring itself within the pylorus and holding the wire in the stomachas shown in FIG. 65. The tissue treatment device 300 is then advancedover the wire to the appropriate location as shown in FIG. 66. Uponcompletion of the procedure, the balloon is deflated and thewire/balloon assembly is removed.

Another embodiment of advancing the tissue treatment device to thestomach is shown in FIGS. 67 through 72. As shown in FIG. 67, a guidewire 580 is positioned into the stomach cavity transorally so that itfollows the curvature of the greater curve of the stomach. Any standardgastric guide wire may be used, such as a guide wire from Savory Gillardhaving a diameter of 0.035 inch. Once the guide wire is in place, aguide catheter tube 582 having a central lumen is placed over the guidewire and routed into the stomach cavity as shown in FIG. 68. Next, theguide wire is removed from the body of the patient, leaving behind theguide catheter tube as shown in FIG. 69. In one embodiment, the guidecatheter tube is configured to be resilient and once positioned in thestomach cavity acts like a retractor by moving unwanted stomach tissueaway from a target area. Further, the tissue treatment device could thenbe placed over the resilient guide catheter tube and advanced into thestomach cavity. This embodiment is advantageous because the resilientguide catheter tube acts like a retractor of tissue in the body of thestomach and also would position the treatment device optimally along thelesser curve.

However, in another embodiment, a stiffening wire 584 or mandrel isplaced down the lumen of the guide catheter tube 582 to the stomachcavity as shown in FIG. 70. The stiffening wire has a preformedretraction shape, and may be made from any shapeable material, such as aresilient plastic, nitinol, or spring steel. In this embodiment, theguide catheter tube would need to be robust enough to contain thepreformed stiffening wire as it is placed down the esophagus. Followingthe insertion of the stiffening wire, the guide catheter tube is removedfrom the patient's body leaving the pre-shaped stiffening wire in placewithin the stomach cavity as shown in FIG. 71. As shown in this figure,the stiffening wire includes a bend 586 toward the lesser curve of thestomach. This allows the tissue treatment device to be directed closerto the lesser curve of the stomach when it is placed within the stomach.Also, the stiffening wire includes a hook shape 588 at its distal endthat helps to retract tissue in the stomach cavity. It has also beencontemplated that the distal end of the stiffening wire could form afull loop to retract unwanted tissue from the tissue treatment device.Referring next to FIG. 72, the tissue treatment device is then insertedinto the stomach cavity over the stiffening wire, where the bend of thestiffening wire directs the tissue treatment device toward the lessercurve of the stomach. After the procedure is completed, the tissuetreatment device is removed from the patient's body followed by thestiffening wire. To remove the stiffening wire, a retrieval catheter maybe positioned over the stiffening wire and then both the retrievalcatheter and stiffening wire may be removed from the patient.

Extra-Gastric Retractors

Laparoscopically placed retractors may also be used in conjunction witha therapeutic device, such as a tissue treatment device 300, and mayeven be used with a tissue treatment device integrated with a retractordevice that is placed transorally within the stomach. Theseextra-gastric retractors are able to manipulate the stomach from outsideof the stomach cavity to better position the stomach for tissueacquisition from within the stomach. Referring now to FIG. 73, alaparoscopic tube 600 is shown having a tube body 602 and an anchoringend 604 at the distal end of the tube body. The anchoring end may be incommunication with a vacuum to suction onto the outer stomach wall, orit may any number of devices, such as a suction cup, graspers, or snare.Once the anchoring end is attached to the stomach, the laparoscopic tubecan be moved in any direction to manipulate the position of the stomach.In one embodiment as shown in FIG. 73, an endoscope 608 placed withinthe stomach transorally may also be used to view the inner stomach wallto provide the physician with assistance in maneuvering the stomach.Once the stomach has been moved to a desired position, the laparoscopictube may be secured in place outside of the patient.

Another embodiment of an extra-gastric retractor is shown in FIG. 74,and includes a catheter 610 or balloon introducer with a balloon 612attached to the distal end. In this embodiment the catheter is advancedthrough the abdominal wall with the balloon deflated at the distal end.Once the distal end of the catheter is positioned near the stomach, theballoon is inflated to maneuver the stomach into a desired position.

Referring to FIG. 75, yet another embodiment of an extra-gastricretractor shown. In this embodiment, a percutaneous endoscopicgastrostomy (“PEG”) tube 620 is shown having a flexible tube 622 and aballoon 624 disposed at the distal end of the flexible tube. Thisprocedure can also be used with an endoscope 626 that is positionedwithin the stomach transorally, so the physician can see the stomachwall through which the PEG tube will pass. In operation, the PEG tubepasses through skin of the abdomen, through a very small incision, andinto the stomach. Once the distal end of the flexible tube is within thestomach cavity, the balloon is inflated at the distal end of the tubewithin the stomach. The stomach may then be maneuvered by pulling theflexible tube in the proximal direction to stretch or move the stomachwall. In one embodiment, a locking or tensioning mechanism 628 can beused outside of the body to hold the flexible tube and the stomach in anew position. By repositioning the stomach, tissue may more easily beacquired by a tissue treatment device positioned within the stomachtransorally. In a similar placement method, the “PEG” tube incision andtube may be used to pass an endoscope up to or into the stomach toassist the user with transoral placement of the treatment devices, orjust to have general visualization of the treatment region.

Additional Integrated Retractor

When performing a therapy with a tissue treatment device as describedabove to form a staple line within the stomach cavity, the jaws(cartridge member and anvil member) of the tissue treatment device areopened and a vacuum is created to gather target tissue into separatevacuum pods included in each jaw of the tissue treatment device. Anoptional septum located between the pods acts to separate the targetedtissue into the separate vacuum pods so that a single region of tissueis in one pod and another single region of tissue is in the other pod.The optional septum is then removed and the jaws are closed to staplethese two regions of tissue together. However, tissue that is supposedto be gathered by one vacuum pod may jump or cross over the septum andenter into the vacuum pod of the other jaw, which prevents the tissuetreatment device from forming a continuous staple line without gaps orholes. To prevent the tissue from crossing over from one vacuum pod tothe other, a barrier may be placed between the pods that is separatefrom the optional septum. In one embodiment, an extension or attachmentcan be connected to the septum so that when the tissue treatment deviceis in a closed configuration, the extension will be contained within thetissue treatment device, and in an opened configuration, the extensioncan be extended above the septum to prevent tissue cross over.

Referring now to FIGS. 76 through 80, another embodiment of a tissuetreatment device 640 is shown that has been modified to include aretractor and a barrier that is extendible between the separate pods ofthe tissue treatment device. The barrier may be flexible so that it canmove between and an extended configuration and a collapsibleconfiguration. The tissue treatment device is similar to the devicedisclosed in U.S. patent application Ser. No. 10/707,303, which alreadyhas been incorporated by reference, and includes a cartridge member 642and an anvil member 644. An atraumatic tip attached to the distal end ofthe tissue treatment device in this embodiment is a split flexible tip646. The tissue treatment device is attached to the distal end of ascope tube or flexible shaft 648 for placement within the stomachcavity. In this embodiment, the retractor is a retractor wire 650. Inthis embodiment, a first end 652 of the retractor wire is attached to atether wire 654, which is attached to a sail 656 and an optional septum658 located between the cartridge member and anvil member. In analternative embodiment, the sail element may serve the function of theseptum in its extended form. With the first end of the retractor wiresecured to the tissue treatment device, the remaining portion of theretractor wire loops around the tissue treatment device and through theflexible shaft 648, where the second end (not shown) is positioned atthe proximal end of the device. In the extended configuration as shownin FIG. 79, the sail acts as a barrier and ensures that the targettissue enters the appropriate vacuum pod without crossing over into theother vacuum pod. It has also been contemplated that that the tissuetreatment device does not include a septum, and the sail 656 is attachedbetween the jaws of the tissue treatment device. In this embodiment, thesail may be attached to the tissue treatment device with a pin or wirethrough hinges between the jaws.

In one embodiment, the first end 652 of the retractor wire 650 is curvedand includes an eyelet 662. An end of the tether 654 is attached to theeyelet of the retractor wire, and the tether may be secured to theseptum 658. When the tissue treatment device 640 is in the deliveryposition with the jaws closed as shown in FIG. 76, the first end of thewire retractor rests inside a gap or slit 664 formed in the splitflexible tip 646, as best shown in FIG. 77. In use, when the tissuetreatment device is positioned within the stomach, the wire retractor isextended by pushing the wire distally, and since the first end of thewire is anchored to the tissue treatment device via the tether, excesswire forms a loop 666 or other space occupying geometry within thestomach cavity. In this retraction position as shown in FIG. 79, theloop formed with the wire retractor pushes or blocks unwanted tissueaway from the tissue treatment device. In some embodiments, the wireretractor is a nitinol wire, although any material, including stainlesssteel or a comparatively stiff polymer, can be used to form the wirestructure.

The retractor wire 650 extends through the flexible shaft 648 to thetissue treatment device 640, where the retractor wire passes throughhinges or tabs attached to the tissue treatment device. In oneembodiment, the retractor wire passes through the hollow hinge pins 667located between the jaws of the tissue treatment device and underneaththe septum 658 as shown in FIG. 79. The split flexible tip has beenremoved from FIG. 79 to better show the position of the retractor wire.In another embodiment, the retractor wire passes through tabs 668 of astrap 670 that is attached to the backside of the tissue treatmentdevice as shown in FIG. 80. Instead of tabs, the strap may form acontinuous lumen that the retractor wire may pass through. FIG. 80 alsoshows the wire retractor passing through an end ring 672 that isattached to the distal end of the flexible shaft. In the deliveryconfiguration for this embodiment, the first end 652 of the retractorwire is positioned within the gap 664 of the split flexible tip 646 byentering the split flexible tip through the gap 664 which extendsthrough the tip at its proximal end. Also, in the extendedconfiguration, the retractor wire will extend through the gap of theflexible tip.

In one embodiment, the shape of the sail 656 is defined by the tetherwire 654, which as shown in FIG. 79 is a triangle, although other shapesmay be used such as circular, oval, or any polygonal shape. The sail maybe formed of a polyimide tape that is wrapped around and secured to thetether. Other materials that can be used to form the sail include anyplastic or flexible material, for example the sail element may be cutfrom a sheet of material, or molded to a particular shape. Such othermaterials may include polyester (e.g., DACRON® from E. I. du Pont deNemours and Company, Wilmington, Del.), polypropylene,polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), nylon, orsilicone. In one embodiment, the tether is also secured through holes ofthe septum 658, however, the sail may be attached directly to theseptum. It has also been contemplated that the first end 652 of theretractor wire 650 is directly attached to the sail without the use of atether wire. In the delivery or closed configuration, the sail folds upand is positioned within the jaws of the tissue treatment device asshown in FIG. 76. Once the tissue treatment device opens and theretractor wire is extended, the sail is raised above the septum as isshown in FIG. 79. As stated previously, the tissue treatment device maynot include the septum, and the sail is then connected between the jawsof the tissue treatment, where it provides the function of the septumelement.

As shown in FIGS. 76-78, the split flexible tip 646 includes acylindrical body 674 with a proximal end 676 and a distal end 678. Thereis also a split or gap 664 formed at the proximal end of the cylindricalbody that is wide enough to house the first end 652 of the retractorwire 650 when the device is in its delivery configuration. Thecylindrical body includes a progressive taper towards the distal end forinsertion through the esophagus. Also, the cylindrical body may includea guide wire lumen 682 so the device can track along a guide wire thathas been positioned within the stomach cavity. The proximal end 676 ofthe split flexible tip can be attached to the distal end of the tissuetreatment device with an adhesive and/or mechanically with pins or apost extending from the tissue treatment device. If adhesive is used,the surface area at the cross section of the proximal end of thecylindrical body 674 should be nearly as large as the surface area ofthe ends of the jaws (cartridge member 642 and anvil member 644). Thesplit or gap 664 allows the split flexible tip to open (see FIG. 77) andclose (see FIG. 76) along with the tissue treatment device, and providesa space for the retractor wire to extend through. In order for the splitflexible tip to open and close and be atraumatic to the tissue of thepatient, it is formed of a flexible elastomeric material, such assilicone rubber.

As best shown in FIG. 80, an endoscope shroud or sleeve 684 is attachedto the backside of the tissue treatment device 640. The shroud providesa passageway for the endoscope, and the passageway starts from thedistal end of the flexible shaft and ends along the backside of thetissue treatment device. It is possible for the shroud to extend anylength along the tissue treatment device, and it may even extend pastthe distal end of the tissue treatment device. In one embodiment, thetubular structure of the shroud is formed by layers of tape, such aspolyimide tape, although any flexible material may be used to form theshroud. In some embodiments the shroud may be molded or formed over amandrel and then attached to the tissue treatment device. It ispreferable that the shroud surface be smooth and flexible to beatraumatic to the esophagus when passed to the treatment area. A collar686 is attached to an end ring 672 located at the distal end of theflexible shaft 648, and the proximal end of the shroud is attached to orwrapped around the collar as shown in FIG. 80. The shroud is thenattached to the tissue treatment device by being wrapped around the samestrap 670 that provides guidance for the retractor wire in someembodiments. In other embodiments that do not include the strap 670, theshroud can be adhesively attached to the tissue treatment device. Inuse, the shroud tube lumen directs the endoscope around the jaws of thetissue treatment device for viewing the procedure. Also, the shroud 684cradles or contains the endoscope to prevent the scope from torquing or“wowing” in a variety of directions that may impact the resultinggeometry of the gastroplasty or pouch.

In operation, the tissue treatment device 640 is positioned within thestomach cavity in its delivery position as shown in FIG. 76. Once inposition within the stomach cavity, the jaws of the tissue treatmentdevice are opened as shown in FIG. 77. During the procedure, a flexibleendoscope 690 can be inserted along the flexible shaft 648 and throughthe shroud 684 to view the tissue treatment device and target area ofthe tissue. The retractor wire 650 is pushed distally through the tissuetreatment device, and because the first end 652 is attached to the sailtether 654, a loop of excess wire 666 is formed as shown in FIG. 78.This action also raises the sail as the retractor wire pulls the tetheraway from the tissue treatment device. In this position the retractorwire blocks or retracts unwanted tissue away from a target area so thetissue treatment device can acquire the desired tissue for staplingwithout gathering unwanted folds. Targeted tissue is drawn into vacuumpods located in the cartridge member 642 and the anvil member 644 when avacuum is created, and the extended sail acts as a barrier to preventtissue from crossing over from one pod to the other. This helps toensure that the staple line formed in the stomach cavity is continuouswithout any gaps or holes.

After acquiring separate regions of tissue in each vacuum pod of thetissue treatment device 640, the septum 658 and sail 656 need to beremoved before the two regions of tissue are stapled together. First,the retractor wire 650 is pulled proximally until its distal end is nearthe split flexible tip 646 and the sail 656 is collapsed as shown inFIG. 81. Next, the septum is pushed distally away from the jaws of thetissue treatment device by a septum wire 692 as shown in FIG. 82. Oncethe septum is removed, the cartridge member 642 and anvil member 644 areclosed together and a staple line is fired within the stomach cavity.After the stapling procedure is completed, the entire device includingthe endoscope is removed from the stomach cavity. The sail is flexibleenough so that when it is removed from the stomach cavity, it does notcause trauma to the esophagus of the patient.

In another embodiment of an integrated device, the sail 656 of theintegrated device may be directly attached to a wire retractor 694 andthe septum 658 as shown in FIG. 83. Although not shown in FIG. 83, thesplit flexible tip 646 can also be attached to the distal end of thetissue treatment device. A first end 696 of the retractor wire 694 isattached to a septum hinge 698 that is hinged to the proximal end of theseptum as shown in FIG. 83. The retractor wire also includes a loop 700that acts as a hinge to allow the retractor wire to fold into thedelivery diameter, which is approximately 54 French. The loop and theseptum hinge allow the sail to fold down to the top of the septum whenthe device is in the delivery configuration, and in this deliveryconfiguration the loop is positioned within the split 664 of the splitflexible tip 646. It has also been contemplated that the loop of thewire can be replaced with a hinge. The sail, which can be a polyimidetape is attached along the distal end of the retractor wire, below theloop and to the first end as shown in the figure, and the sail isattached to the septum, leaving one side of the triangular shaped sailunattached. In use, the septum and sail are removed from the tissuetreatment device in a similar manner as described above. Also, inanother embodiment, the tissue treatment device may not include theseptum and the septum hinge and sail may be connected between the jawsof the tissue treatment device.

In yet another embodiment, the wire retractor and sail are replaced witha balloon that performs the same functions, i.e., retracts unwantedtissue away from the target area and prevents tissue from crossing overfrom one vacuum pod to the other. An additional advantage of the balloonretractor is that it can funnel target tissue into the jaws of thetissue treatment device. A balloon retractor 702 as shown in FIGS. 84-86includes an inlet 704 that is in fluid communication with the shroud684, a top hemisphere 706 and a bottom hemisphere 708. The bottomhemisphere is attached to the top edge of the septum 658, preferablythrough an adhesive. In another embodiment, the bottom hemisphere isattached between the jaws of the tissue treatment device without theseptum. The balloon may be compliant or non-compliant, and can be formedwith polyester or other such material previously described above, thatis transparent to allow the endoscope 690 to view the target area fromwithin the balloon. Within the stomach cavity, the top hemisphere of theballoon will manage the fundus tissue of the stomach cavity, and itsvolume will occupy more stomach wall area than a wire. While the tophemisphere retracts unwanted tissue away from the tissue treatmentdevice, the bottom hemisphere, which is attached to the septum, actsmuch like the sail described above to prevent tissue from crossing orjumping over the septum and into the alternative vacuum pod of thetissue treatment device.

In use, the balloon 702 is deflated and folded along the tissuetreatment device 640 for delivery to the stomach cavity. Once inposition, the jaws of the tissue treatment device are opened and afluid, either air or liquid, is sent through the flexible shaft 648 or acatheter disposed within the flexible shaft to inflate the balloonthrough its inlet 704. In one embodiment, the inlet is directly in fluidcommunication with the flexible shaft or catheter, and in anotherembodiment the inlet is in communication with the flexible shaft orcatheter by being in communication with the shroud 684. The balloonexpands to retract tissue, and then a vacuum is created within pods ofthe cartridge member 642 and anvil member 644 to gather targeted tissue.The bottom hemisphere keeps the regions of tissue separate in each ofthe pods. Once the tissue is acquired, the balloon is then deflated, andthen removed from between the jaws of the tissue treatment device. In anembodiment including a septum, the septum is also removed along with theballoon. The jaws of the tissue treatment device are then closed tosecure the regions of tissue together with a staple line. The tissuetreatment device is then removed from the stomach.

The cross-sectional shape of the balloon retractor 702 is shown in FIG.86, and in this embodiment the balloon has a generally circular shape.Other cross-sectional shapes, such as those shown in FIGS. 87 and 88,may also be used. The balloon 710 of FIG. 87 is wedge shaped, and theformed balloon 712 of FIG. 88 has a generally oval shape. All of theseshapes provide enough capture space 714 above the jaws of the tissuetreatment device 640 to gather a sufficient amount of targeted tissuewithin the vacuum pods located within the cartridge member 642 and anvilmember 644. The bottom hemisphere of the balloon can be tailored in anymanner to allow for more or less volume in the capture space.

Although the present invention has been described in terms of certainpreferred embodiments, other embodiments that are apparent to those ofordinary skill in the art are also within the scope of the invention.Accordingly, the scope of the invention is intended to be defined onlyby reference to the appended claims. While the dimensions, types ofmaterials described herein are intended to define the parameters of theinvention, they are by no means limiting and are exemplary embodiments.

1. A device for managing tissue in an organ, comprising: a flexible,elongated body having a proximal end and a distal end and a workinglumen extending therebetween; a gastroplasty device for tissueacquisition and fixation to create a partition within a hollow bodyorgan disposed at the distal end of the elongated body; and a retractorformed of elastomeric material connected to the gastroplasty device, theretractor including a cylindrical proximal portion transitioning to agenerally flat distal portion, and the flat distal portion connected toa cable and being moveable from a straight position to an arced positionto manage tissue of the organ relative to the gastroplasty device whenthe cable is actuated.
 2. The device of claim 1, wherein the retractorincludes spring elements disposed within the elastomeric material tobias the retractor into the straight position.
 3. The device of claim 2,wherein the spring elements are formed of nitinol.
 4. The device ofclaim 2, wherein the retractor includes guide tubes disposed within theflat portion to house the spring elements.